Trial Outcomes & Findings for Effect of GSK3640254 on the Pharmacokinetics of a Combination Oral Contraceptive (NCT NCT03984825)

Results Overview

Blood samples were collected at indicated time points for the analysis of AUC (0-tau) of EE. PK parameters were calculated by standard non-compartmental analysis. The PK population included all participants who underwent plasma PK sampling and had evaluable PK parameters estimated.

Recruitment status

COMPLETED

Study phase

PHASE1

Target enrollment

23 participants

Primary outcome timeframe

Day 10: Pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 7, 12 hours and Day 11: 24 hours

Results posted on

2020-08-27

Participant Flow

This was a Phase 1, open-label, fixed-sequence, 1-way drug-drug interaction (DDI) study to assess the Pharmacokinetic (PK), pharmacodynamic (PD), safety, and tolerability of GSK3640254 and an oral contraceptive containing Ethinyl estradiol/Levonorgestrel (EE/LNG, Portia) when administered alone and in combination in healthy female participants.

A total of 23 participants were enrolled in the study

Participant milestones

Participant milestones
Measure	Portia Followed by Portia + GSK3640254 Participants in Run-in period received Portia (0.03 milligram \[mg\] EE/0.15 mg LNG) once daily (QD) on Day -3 through Day -1. Participants in Treatment Period 1 received Portia (0.3 mg EE/ 0.15 mg LNG) QD on Day 1 through Day 10. In Treatment Period 2 participants received Portia QD co-administered with GSK3640254 200 mg QD on Day 11 through Day 21. There was no washout period between two periods.
Run-in Period (Day -3 to -1) STARTED	23
Run-in Period (Day -3 to -1) COMPLETED	23
Run-in Period (Day -3 to -1) NOT COMPLETED	0
Treatment Period 1 (Day 1 to 10) STARTED	23
Treatment Period 1 (Day 1 to 10) COMPLETED	21
Treatment Period 1 (Day 1 to 10) NOT COMPLETED	2
Treatment Period 2 (Day 11 to 21) STARTED	21
Treatment Period 2 (Day 11 to 21) COMPLETED	17
Treatment Period 2 (Day 11 to 21) NOT COMPLETED	4

Reasons for withdrawal

Reasons for withdrawal
Measure	Portia Followed by Portia + GSK3640254 Participants in Run-in period received Portia (0.03 milligram \[mg\] EE/0.15 mg LNG) once daily (QD) on Day -3 through Day -1. Participants in Treatment Period 1 received Portia (0.3 mg EE/ 0.15 mg LNG) QD on Day 1 through Day 10. In Treatment Period 2 participants received Portia QD co-administered with GSK3640254 200 mg QD on Day 11 through Day 21. There was no washout period between two periods.
Treatment Period 1 (Day 1 to 10) Sponsor decision	2
Treatment Period 2 (Day 11 to 21) Physician Decision	1
Treatment Period 2 (Day 11 to 21) Adverse Event	3

Baseline Characteristics

Effect of GSK3640254 on the Pharmacokinetics of a Combination Oral Contraceptive

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Portia Followed by Portia + GSK3640254 n=23 Participants Participants in Run-in period received Portia (0.03 milligram \[mg\] EE/0.15 mg LNG) once daily (QD) on Day -3 through Day -1. Participants in Treatment Period 1 received Portia (0.3 mg EE/ 0.15 mg LNG) QD on Day 1 through Day 10. In Treatment Period 2 participants received Portia QD co-administered with GSK3640254 200 mg QD on Day 11 through Day 21. There was no washout period between two periods.
Age, Continuous	34.7 Years STANDARD_DEVIATION 7.82 • n=5 Participants
Sex: Female, Male Female	23 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants
Race/Ethnicity, Customized American Indian or Alaska Native	1 Participants n=5 Participants
Race/Ethnicity, Customized Asian-Central/South Asian Heritage	1 Participants n=5 Participants
Race/Ethnicity, Customized Black or African American	12 Participants n=5 Participants
Race/Ethnicity, Customized White	9 Participants n=5 Participants

PRIMARY outcome

Timeframe: Day 10: Pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 7, 12 hours and Day 11: 24 hours

Population: PK Population.

Blood samples were collected at indicated time points for the analysis of AUC (0-tau) of EE. PK parameters were calculated by standard non-compartmental analysis. The PK population included all participants who underwent plasma PK sampling and had evaluable PK parameters estimated.

Outcome measures

Outcome measures
Measure	Portia (0.3 mg EE/ 0.15 mg LNG) n=23 Participants Participants in period 1 received Portia (0.3 mg of EE and 0.15 mg LNG) QD on Day 1 through Day 10.	Portia (0.3 mg EE/ 0.15 mg LNG)+GSK3640254 Participants in treatment period 2 were co-administered with GSK3640254 200 mg QD along with Portia from Day 11 through Day 21.
Period 1: Area Under the Plasma Concentration-time Curve From Time 0 to the End of the Dosing Interval at Steady State (AUC [0-tau]) of EE	748.7 Hour*picograms per milliliter Geometric Coefficient of Variation 25.2	—

PRIMARY outcome

Timeframe: Day 21: Pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 7, 12 and 24 hours post dose

Population: PK Population.

Blood samples were collected at indicated time points for the analysis of AUC (0-tau) of EE. PK parameters were calculated by standard non-compartmental analysis.

Outcome measures

Outcome measures
Measure	Portia (0.3 mg EE/ 0.15 mg LNG) n=17 Participants Participants in period 1 received Portia (0.3 mg of EE and 0.15 mg LNG) QD on Day 1 through Day 10.	Portia (0.3 mg EE/ 0.15 mg LNG)+GSK3640254 Participants in treatment period 2 were co-administered with GSK3640254 200 mg QD along with Portia from Day 11 through Day 21.
Period 2: AUC (0-tau) of EE	735.8 Hour*picograms per milliliter Geometric Coefficient of Variation 23.6	—

PRIMARY outcome

Timeframe: Day 10: Pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 7, 12 hours and Day 11: 24 hours

Population: PK Population.

Blood samples were collected at indicated time points for the analysis of AUC (0-tau) of LNG. PK parameters were calculated by standard non-compartmental analysis.

Outcome measures

Outcome measures
Measure	Portia (0.3 mg EE/ 0.15 mg LNG) n=23 Participants Participants in period 1 received Portia (0.3 mg of EE and 0.15 mg LNG) QD on Day 1 through Day 10.	Portia (0.3 mg EE/ 0.15 mg LNG)+GSK3640254 Participants in treatment period 2 were co-administered with GSK3640254 200 mg QD along with Portia from Day 11 through Day 21.
Period 1:AUC (0-tau) of LNG	68682.4 Hour*picograms per milliliter Geometric Coefficient of Variation 40.3	—

PRIMARY outcome

Timeframe: Day 21: Pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 7, 12 and 24 hours post dose

Population: PK Population.

Blood samples were collected at indicated time points for the analysis of AUC (0-tau) of LNG. PK parameters were calculated by standard non-compartmental analysis.

Outcome measures

Outcome measures
Measure	Portia (0.3 mg EE/ 0.15 mg LNG) n=17 Participants Participants in period 1 received Portia (0.3 mg of EE and 0.15 mg LNG) QD on Day 1 through Day 10.	Portia (0.3 mg EE/ 0.15 mg LNG)+GSK3640254 Participants in treatment period 2 were co-administered with GSK3640254 200 mg QD along with Portia from Day 11 through Day 21.
Period 2: AUC (0-tau) of LNG	75412.0 Hour*picograms per milliliter Geometric Coefficient of Variation 40.7	—

PRIMARY outcome

Timeframe: Day 10: Pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 7, 12 hours and Day 11: 24 hours

Population: PK Population.

Blood samples were collected at indicated time points for the analysis of Cmax and Ctau of EE. PK parameters were calculated by standard non-compartmental analysis.

Outcome measures

Outcome measures
Measure	Portia (0.3 mg EE/ 0.15 mg LNG) n=23 Participants Participants in period 1 received Portia (0.3 mg of EE and 0.15 mg LNG) QD on Day 1 through Day 10.	Portia (0.3 mg EE/ 0.15 mg LNG)+GSK3640254 Participants in treatment period 2 were co-administered with GSK3640254 200 mg QD along with Portia from Day 11 through Day 21.
Period 1: Maximum Observed Concentration (Cmax) and Plasma Concentration at the End of the Dosing Interval (Ctau) of EE Cmax	70.01 Picograms per milliliter Geometric Coefficient of Variation 34.9	—
Period 1: Maximum Observed Concentration (Cmax) and Plasma Concentration at the End of the Dosing Interval (Ctau) of EE Ctau	14.83 Picograms per milliliter Geometric Coefficient of Variation 32.1	—

PRIMARY outcome

Timeframe: Day 21: Pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 7, 12 and 24 hours

Population: PK Population.

Blood samples were collected at indicated time points for the analysis of Cmax and Ctau of EE. PK parameters were calculated by standard non-compartmental analysis.

Outcome measures

Outcome measures
Measure	Portia (0.3 mg EE/ 0.15 mg LNG) n=17 Participants Participants in period 1 received Portia (0.3 mg of EE and 0.15 mg LNG) QD on Day 1 through Day 10.	Portia (0.3 mg EE/ 0.15 mg LNG)+GSK3640254 Participants in treatment period 2 were co-administered with GSK3640254 200 mg QD along with Portia from Day 11 through Day 21.
Period 2: Cmax and Ctau of EE Cmax	68.47 Picograms per milliliter Geometric Coefficient of Variation 33.3	—
Period 2: Cmax and Ctau of EE Ctau	15.69 Picograms per milliliter Geometric Coefficient of Variation 27.8	—

PRIMARY outcome

Timeframe: Day 10: Pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 7, 12 hours and Day 11: 24 hours

Population: PK Population.

Blood samples were collected at indicated time points for the analysis of Cmax and Ctau of LNG. PK parameters were calculated by standard non-compartmental analysis.

Outcome measures

Outcome measures
Measure	Portia (0.3 mg EE/ 0.15 mg LNG) n=23 Participants Participants in period 1 received Portia (0.3 mg of EE and 0.15 mg LNG) QD on Day 1 through Day 10.	Portia (0.3 mg EE/ 0.15 mg LNG)+GSK3640254 Participants in treatment period 2 were co-administered with GSK3640254 200 mg QD along with Portia from Day 11 through Day 21.
Period 1:Cmax and Ctau of LNG Cmax	5806 Picograms per milliliter Geometric Coefficient of Variation 39.3	—
Period 1:Cmax and Ctau of LNG Ctau	1870 Picograms per milliliter Geometric Coefficient of Variation 49.0	—

PRIMARY outcome

Timeframe: Day 21: Pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 7, 12 and 24 hours post dose

Population: PK Population.

Blood samples were collected at indicated time points for the analysis of Cmax and Ctau of LNG. PK parameters were calculated by standard non-compartmental analysis.

Outcome measures

Outcome measures
Measure	Portia (0.3 mg EE/ 0.15 mg LNG) n=17 Participants Participants in period 1 received Portia (0.3 mg of EE and 0.15 mg LNG) QD on Day 1 through Day 10.	Portia (0.3 mg EE/ 0.15 mg LNG)+GSK3640254 Participants in treatment period 2 were co-administered with GSK3640254 200 mg QD along with Portia from Day 11 through Day 21.
Period 2: Cmax and Ctau of LNG Cmax	5948 Picograms per milliliter Geometric Coefficient of Variation 36.7	—
Period 2: Cmax and Ctau of LNG Ctau	2163 Picograms per milliliter Geometric Coefficient of Variation 46.6	—

SECONDARY outcome

Timeframe: At Day 1 and Day 10

Population: PD concentration Population.

Serum samples were collected for the analysis of progesterone concentration levels when GSK3640254 is co-administered with EE/LNG. PD concentration Population comprised of all participants who underwent plasma PD sampling and had evaluable PD assay results.

Outcome measures

Outcome measures
Measure	Portia (0.3 mg EE/ 0.15 mg LNG) n=23 Participants Participants in period 1 received Portia (0.3 mg of EE and 0.15 mg LNG) QD on Day 1 through Day 10.	Portia (0.3 mg EE/ 0.15 mg LNG)+GSK3640254 Participants in treatment period 2 were co-administered with GSK3640254 200 mg QD along with Portia from Day 11 through Day 21.
Period 1: Effect of GSK3640254 on PD of EE/LNG- Serum Progesterone Level Day 1	6.103 Nanomoles per liter Standard Deviation 5.0947	—
Period 1: Effect of GSK3640254 on PD of EE/LNG- Serum Progesterone Level Day 10	4.410 Nanomoles per liter Standard Deviation 1.5370	—

SECONDARY outcome

Timeframe: At Days 11, 21 and 22

Population: PD concentration Population. Only those participants with data available at specified time points has been presented (represented by n=X in the category titles).

Serum samples were collected for the analysis progesterone concentration levels when GSK3640254 is co-administered with EE/LNG.

Outcome measures

Outcome measures
Measure	Portia (0.3 mg EE/ 0.15 mg LNG) n=21 Participants Participants in period 1 received Portia (0.3 mg of EE and 0.15 mg LNG) QD on Day 1 through Day 10.	Portia (0.3 mg EE/ 0.15 mg LNG)+GSK3640254 Participants in treatment period 2 were co-administered with GSK3640254 200 mg QD along with Portia from Day 11 through Day 21.
Period 2: Effect of GSK3640254 on PD of EE/LNG- Serum Progesterone Level Day 11, n=21	3.906 Nanomoles per liter Standard Deviation 1.2178	—
Period 2: Effect of GSK3640254 on PD of EE/LNG- Serum Progesterone Level Day 21, n=17	3.618 Nanomoles per liter Standard Deviation 0.9386	—
Period 2: Effect of GSK3640254 on PD of EE/LNG- Serum Progesterone Level Day 22, n=17	3.988 Nanomoles per liter Standard Deviation 1.4316	—

SECONDARY outcome

Timeframe: At Day 1 and Day 10

Population: PD concentration Population.

Serum samples were collected for the analysis of effect of GSK3640254 on LH and FSH.

Outcome measures

Outcome measures
Measure	Portia (0.3 mg EE/ 0.15 mg LNG) n=23 Participants Participants in period 1 received Portia (0.3 mg of EE and 0.15 mg LNG) QD on Day 1 through Day 10.	Portia (0.3 mg EE/ 0.15 mg LNG)+GSK3640254 Participants in treatment period 2 were co-administered with GSK3640254 200 mg QD along with Portia from Day 11 through Day 21.
Period 1: Absolute Values of Effect of GSK3640254 on Luteinizing Hormone (LH) and Follicle-stimulating Hormone (FSH) LH, Day 1	9.500 International units per liter Standard Deviation 11.0104	—
Period 1: Absolute Values of Effect of GSK3640254 on Luteinizing Hormone (LH) and Follicle-stimulating Hormone (FSH) LH, Day 10	2.747 International units per liter Standard Deviation 1.9554	—
Period 1: Absolute Values of Effect of GSK3640254 on Luteinizing Hormone (LH) and Follicle-stimulating Hormone (FSH) FSH, Day 1	5.109 International units per liter Standard Deviation 3.7754	—
Period 1: Absolute Values of Effect of GSK3640254 on Luteinizing Hormone (LH) and Follicle-stimulating Hormone (FSH) FSH, Day 10	2.215 International units per liter Standard Deviation 1.4567	—

SECONDARY outcome

Timeframe: At Days 11, 21 and 22

Population: PD concentration Population. Only those participants with data available at specified time points has been presented (represented by n=X in the category titles).

Serum samples were collected for the analysis of effect of GSK3640254 on LH and FSH.

Outcome measures

Outcome measures
Measure	Portia (0.3 mg EE/ 0.15 mg LNG) n=21 Participants Participants in period 1 received Portia (0.3 mg of EE and 0.15 mg LNG) QD on Day 1 through Day 10.	Portia (0.3 mg EE/ 0.15 mg LNG)+GSK3640254 Participants in treatment period 2 were co-administered with GSK3640254 200 mg QD along with Portia from Day 11 through Day 21.
Period 2: Absolute Values of Effect of GSK3640254 on LH and FSH LH, Day 11, n=21	2.255 International units per liter Standard Deviation 1.6299	—
Period 2: Absolute Values of Effect of GSK3640254 on LH and FSH LH, Day 21, n=17	1.202 International units per liter Standard Deviation 0.6667	—
Period 2: Absolute Values of Effect of GSK3640254 on LH and FSH LH, Day 22, n=17	1.287 International units per liter Standard Deviation 0.8298	—
Period 2: Absolute Values of Effect of GSK3640254 on LH and FSH FSH, Day 11, n=21	2.162 International units per liter Standard Deviation 1.4388	—
Period 2: Absolute Values of Effect of GSK3640254 on LH and FSH FSH, Day 21, n=17	1.535 International units per liter Standard Deviation 0.8285	—
Period 2: Absolute Values of Effect of GSK3640254 on LH and FSH FSH, Day 22, n=17	1.638 International units per liter Standard Deviation 1.2380	—

SECONDARY outcome

Timeframe: Day 21: Pre-dose, 1, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8 and 12 and 24 hours post dose

Population: PK Population.

Blood samples were collected at indicated time points for the analysis of AUC (0-tau) of GSK3640254. PK parameters were calculated by standard non-compartmental analysis.

Outcome measures

Outcome measures
Measure	Portia (0.3 mg EE/ 0.15 mg LNG) n=17 Participants Participants in period 1 received Portia (0.3 mg of EE and 0.15 mg LNG) QD on Day 1 through Day 10.	Portia (0.3 mg EE/ 0.15 mg LNG)+GSK3640254 Participants in treatment period 2 were co-administered with GSK3640254 200 mg QD along with Portia from Day 11 through Day 21.
Period 2: AUC (0-tau) of GSK3640254	30.22 Hour*micrograms per milliliter Geometric Coefficient of Variation 23.1	—

SECONDARY outcome

Timeframe: Day 21: Pre-dose, 1, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8 and 12 and 24 hours post dose

Population: PK Population.

Blood samples were collected at indicated time points for the analysis of Cmax and Ctau of GSK3640254. PK parameters were calculated by standard non-compartmental analysis.

Outcome measures

Outcome measures
Measure	Portia (0.3 mg EE/ 0.15 mg LNG) n=17 Participants Participants in period 1 received Portia (0.3 mg of EE and 0.15 mg LNG) QD on Day 1 through Day 10.	Portia (0.3 mg EE/ 0.15 mg LNG)+GSK3640254 Participants in treatment period 2 were co-administered with GSK3640254 200 mg QD along with Portia from Day 11 through Day 21.
Period 2: Cmax and Ctau of GSK3640254 Cmax	1.780 Micrograms per milliliter Geometric Coefficient of Variation 30.4	—
Period 2: Cmax and Ctau of GSK3640254 Ctau	0.9663 Micrograms per milliliter Geometric Coefficient of Variation 27.1	—

SECONDARY outcome

Timeframe: Day 21: Pre-dose, 1, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8 and 12 hours; Day 22: 24 hours; Day 23: 48 hours; Day 24: 72 hours and Day 25: 96 hours

Population: PK Population. Only those participants with data available at specified time points were analyzed.

Blood samples were collected at indicated time points for the analysis of t1/2 of GSK3640254. PK parameters were calculated by standard non-compartmental analysis.

Outcome measures

Outcome measures
Measure	Portia (0.3 mg EE/ 0.15 mg LNG) n=14 Participants Participants in period 1 received Portia (0.3 mg of EE and 0.15 mg LNG) QD on Day 1 through Day 10.	Portia (0.3 mg EE/ 0.15 mg LNG)+GSK3640254 Participants in treatment period 2 were co-administered with GSK3640254 200 mg QD along with Portia from Day 11 through Day 21.
Period 2: Apparent Terminal Phase Half-life (t1/2) of GSK3640254	25.656 Hours Geometric Coefficient of Variation 19.1	—

SECONDARY outcome

Timeframe: Day 21: Pre-dose, 1, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8 and 12 and 24 hours post dose

Population: PK Population.

Blood samples were collected at indicated time points for the analysis of Tmax of GSK3640254. PK parameters were calculated by standard non-compartmental analysis.

Outcome measures

Outcome measures
Measure	Portia (0.3 mg EE/ 0.15 mg LNG) n=17 Participants Participants in period 1 received Portia (0.3 mg of EE and 0.15 mg LNG) QD on Day 1 through Day 10.	Portia (0.3 mg EE/ 0.15 mg LNG)+GSK3640254 Participants in treatment period 2 were co-administered with GSK3640254 200 mg QD along with Portia from Day 11 through Day 21.
Period 2: Time of Maximum Observed Concentration (Tmax) of GSK3640254	4.500 Hours Interval 3.5 to 24.0	—

SECONDARY outcome

Timeframe: Day 10: Pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 7, 12 hours and Day 11: 24 hours

Population: PK Population.

Blood samples were collected at indicated time points for the analysis of t1/2 of EE. PK parameters were calculated by standard non-compartmental analysis.

Outcome measures

Outcome measures
Measure	Portia (0.3 mg EE/ 0.15 mg LNG) n=23 Participants Participants in period 1 received Portia (0.3 mg of EE and 0.15 mg LNG) QD on Day 1 through Day 10.	Portia (0.3 mg EE/ 0.15 mg LNG)+GSK3640254 Participants in treatment period 2 were co-administered with GSK3640254 200 mg QD along with Portia from Day 11 through Day 21.
Period 1: t1/2 of EE	NA Hours Geometric Coefficient of Variation NA Not applicable(NA) indicated t1/2 could not be calculated as we need atleast 3 timepoints after Cmax within same participant and this criteria was not fulfilled due to insufficient sampling(upto 24hours,which was less than 3times estimated half life)	—

SECONDARY outcome

Timeframe: Day 21: Pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 7, 12 hours and Day 22: 24 hours; Day 23: 48 hours and Day 24: 72 hours

Population: PK Population.

Blood samples were collected at indicated time points for the analysis of t1/2 of EE. PK parameters were calculated by standard non-compartmental analysis.

Outcome measures

Outcome measures
Measure	Portia (0.3 mg EE/ 0.15 mg LNG) n=17 Participants Participants in period 1 received Portia (0.3 mg of EE and 0.15 mg LNG) QD on Day 1 through Day 10.	Portia (0.3 mg EE/ 0.15 mg LNG)+GSK3640254 Participants in treatment period 2 were co-administered with GSK3640254 200 mg QD along with Portia from Day 11 through Day 21.
Period 2: t1/2 of EE	20.215 Hours Geometric Coefficient of Variation 17.4	—

SECONDARY outcome

Timeframe: Day 10: Pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 7, 12 hours and Day 11: 24 hours

Population: PK Population.

Blood samples were collected at indicated time points for the analysis of Tmax of EE. PK parameters were calculated by standard non-compartmental analysis.

Outcome measures

Outcome measures
Measure	Portia (0.3 mg EE/ 0.15 mg LNG) n=23 Participants Participants in period 1 received Portia (0.3 mg of EE and 0.15 mg LNG) QD on Day 1 through Day 10.	Portia (0.3 mg EE/ 0.15 mg LNG)+GSK3640254 Participants in treatment period 2 were co-administered with GSK3640254 200 mg QD along with Portia from Day 11 through Day 21.
Period 1: Tmax of EE	2.000 Hours Interval 1.0 to 4.0	—

SECONDARY outcome

Timeframe: Day 21: Pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 7, 12 hours and Day 22: 24 hours; Day 23: 48 hours and Day 24: 72 hours

Population: PK Population.

Blood samples were collected at indicated time points for the analysis of Tmax of EE. PK parameters were calculated by standard non-compartmental analysis.

Outcome measures

Outcome measures
Measure	Portia (0.3 mg EE/ 0.15 mg LNG) n=17 Participants Participants in period 1 received Portia (0.3 mg of EE and 0.15 mg LNG) QD on Day 1 through Day 10.	Portia (0.3 mg EE/ 0.15 mg LNG)+GSK3640254 Participants in treatment period 2 were co-administered with GSK3640254 200 mg QD along with Portia from Day 11 through Day 21.
Period 2: Tmax of EE	2.000 Hours Interval 1.0 to 4.0	—

SECONDARY outcome

Timeframe: Day 10: Pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 7, 12 hours and Day 11: 24 hours

Population: PK Population.

Blood samples were collected at indicated time points for the analysis of t1/2 of LNG. PK parameters were calculated by standard non-compartmental analysis.

Outcome measures

Outcome measures
Measure	Portia (0.3 mg EE/ 0.15 mg LNG) n=23 Participants Participants in period 1 received Portia (0.3 mg of EE and 0.15 mg LNG) QD on Day 1 through Day 10.	Portia (0.3 mg EE/ 0.15 mg LNG)+GSK3640254 Participants in treatment period 2 were co-administered with GSK3640254 200 mg QD along with Portia from Day 11 through Day 21.
Period 1: t1/2 of LNG	NA Hours Geometric Coefficient of Variation NA Not applicable(NA) indicated t1/2 could not be calculated as we need atleast 3 timepoints after Cmax within same participant and this criteria was not fulfilled due to insufficient sampling(upto 24hours,which was less than 3times estimated half life)	—

SECONDARY outcome

Timeframe: Day 21: Pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 7, 12 hours; Day 22: 24 hours; Day 23: 48 hours and Day 24: 72 hours

Population: PK Population. Only those participants with data available at specified time points were analyzed.

Blood samples were collected at indicated time points for the analysis of t1/2 of LNG. PK parameters were calculated by standard non-compartmental analysis.

Outcome measures

Outcome measures
Measure	Portia (0.3 mg EE/ 0.15 mg LNG) n=4 Participants Participants in period 1 received Portia (0.3 mg of EE and 0.15 mg LNG) QD on Day 1 through Day 10.	Portia (0.3 mg EE/ 0.15 mg LNG)+GSK3640254 Participants in treatment period 2 were co-administered with GSK3640254 200 mg QD along with Portia from Day 11 through Day 21.
Period 2: t1/2 of LNG	30.100 Hours Geometric Coefficient of Variation 4.2	—

SECONDARY outcome

Timeframe: Day 10: Pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 7, 12 hours and Day 11: 24 hours

Population: PK Population.

Blood samples were collected at indicated time points for the analysis of Tmax of LNG. PK parameters were calculated by standard non-compartmental analysis.

Outcome measures

Outcome measures
Measure	Portia (0.3 mg EE/ 0.15 mg LNG) n=23 Participants Participants in period 1 received Portia (0.3 mg of EE and 0.15 mg LNG) QD on Day 1 through Day 10.	Portia (0.3 mg EE/ 0.15 mg LNG)+GSK3640254 Participants in treatment period 2 were co-administered with GSK3640254 200 mg QD along with Portia from Day 11 through Day 21.
Period 1: Tmax of LNG	2.000 Hours Interval 0.5 to 4.0	—

SECONDARY outcome

Timeframe: Day 21: Pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 7, 12 hours; Day 22: 24 hours; Day 23: 48 hours and Day 24: 72 hours

Population: PK Population.

Blood samples were collected at indicated time points for the analysis of Tmax of LNG. PK parameters were calculated by standard non-compartmental analysis.

Outcome measures

Outcome measures
Measure	Portia (0.3 mg EE/ 0.15 mg LNG) n=17 Participants Participants in period 1 received Portia (0.3 mg of EE and 0.15 mg LNG) QD on Day 1 through Day 10.	Portia (0.3 mg EE/ 0.15 mg LNG)+GSK3640254 Participants in treatment period 2 were co-administered with GSK3640254 200 mg QD along with Portia from Day 11 through Day 21.
Period 2: Tmax of LNG	2.000 Hours Interval 1.0 to 4.0	—

SECONDARY outcome

Timeframe: Up to Day 25

Population: Safety Population.

An adverse event (AE) is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. An SAE is defined as any untoward medical occurrence that, at any dose: results in death; is life-threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent disability/incapacity; is a congenital anomaly/birth defect; other important medical events that may jeopardize the participant or may require medical or surgical intervention to prevent one of the other outcomes listed before. Safety Population comprised of all participants who received at least one dose of study medication.

Outcome measures

Outcome measures
Measure	Portia (0.3 mg EE/ 0.15 mg LNG) n=23 Participants Participants in period 1 received Portia (0.3 mg of EE and 0.15 mg LNG) QD on Day 1 through Day 10.	Portia (0.3 mg EE/ 0.15 mg LNG)+GSK3640254 n=21 Participants Participants in treatment period 2 were co-administered with GSK3640254 200 mg QD along with Portia from Day 11 through Day 21.
Number of Participants With Non-serious Adverse Events (Non-SAEs) and Serious Adverse Events (SAE) (Treatment Period) Non-serious AE	5 Participants	9 Participants
Number of Participants With Non-serious Adverse Events (Non-SAEs) and Serious Adverse Events (SAE) (Treatment Period) SAE	0 Participants	0 Participants

SECONDARY outcome

Timeframe: From Day -3 to Day -1

Population: Safety Population.

An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. An SAE is defined as any untoward medical occurrence that, at any dose: results in death; is life-threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent disability/incapacity; is a congenital anomaly/birth defect; other important medical events that may jeopardize the participant or may require medical or surgical intervention to prevent one of the other outcomes listed before.

Outcome measures

Outcome measures
Measure	Portia (0.3 mg EE/ 0.15 mg LNG) n=23 Participants Participants in period 1 received Portia (0.3 mg of EE and 0.15 mg LNG) QD on Day 1 through Day 10.	Portia (0.3 mg EE/ 0.15 mg LNG)+GSK3640254 Participants in treatment period 2 were co-administered with GSK3640254 200 mg QD along with Portia from Day 11 through Day 21.
Number of Participants With Non-SAEs and SAE (Run-in Period) Non-serious AE	0 Participants	—
Number of Participants With Non-SAEs and SAE (Run-in Period) SAE	0 Participants	—

SECONDARY outcome

Timeframe: Baseline (Day 1, Pre-dose) and at Day 10

Population: Safety Population.

Blood samples were collected at indicated time points for the analysis of clinical chemistry parameters including Glucose, cholesterol, triglycerides, anion gap, calcium, carbon dioxide, chloride, phosphate, potassium, sodium and BUN. Baseline is defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, within each treatment. Change from Baseline was defined as post-dose visit value minus Baseline value.

Outcome measures

Outcome measures
Measure	Portia (0.3 mg EE/ 0.15 mg LNG) n=23 Participants Participants in period 1 received Portia (0.3 mg of EE and 0.15 mg LNG) QD on Day 1 through Day 10.	Portia (0.3 mg EE/ 0.15 mg LNG)+GSK3640254 Participants in treatment period 2 were co-administered with GSK3640254 200 mg QD along with Portia from Day 11 through Day 21.
Period 1: Change From Baseline in Clinical Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium and Blood Urea Nitrogen (BUN) Glucose	-0.217 Millimoles per liter Standard Deviation 0.3567	—
Period 1: Change From Baseline in Clinical Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium and Blood Urea Nitrogen (BUN) Cholesterol	-0.153 Millimoles per liter Standard Deviation 0.3219	—
Period 1: Change From Baseline in Clinical Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium and Blood Urea Nitrogen (BUN) Triglycerides	-0.049 Millimoles per liter Standard Deviation 0.2231	—
Period 1: Change From Baseline in Clinical Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium and Blood Urea Nitrogen (BUN) Anion gap	1.3 Millimoles per liter Standard Deviation 1.66	—
Period 1: Change From Baseline in Clinical Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium and Blood Urea Nitrogen (BUN) Calcium	0.039 Millimoles per liter Standard Deviation 0.0626	—
Period 1: Change From Baseline in Clinical Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium and Blood Urea Nitrogen (BUN) Carbon dioxide	-1.8 Millimoles per liter Standard Deviation 1.30	—
Period 1: Change From Baseline in Clinical Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium and Blood Urea Nitrogen (BUN) Chloride	0.1 Millimoles per liter Standard Deviation 1.82	—
Period 1: Change From Baseline in Clinical Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium and Blood Urea Nitrogen (BUN) Phosphate	-0.030 Millimoles per liter Standard Deviation 0.1056	—
Period 1: Change From Baseline in Clinical Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium and Blood Urea Nitrogen (BUN) Potassium	-0.03 Millimoles per liter Standard Deviation 0.343	—
Period 1: Change From Baseline in Clinical Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium and Blood Urea Nitrogen (BUN) Sodium	-0.3 Millimoles per liter Standard Deviation 2.12	—
Period 1: Change From Baseline in Clinical Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium and Blood Urea Nitrogen (BUN) BUN	-0.180 Millimoles per liter Standard Deviation 0.5956	—

SECONDARY outcome

Timeframe: Baseline (Day 10) and at Days 21 and 24

Population: Safety Population. Only those participants with data available at specified time points were analyzed.

Blood samples were collected at indicated time points for the analysis of clinical chemistry parameters including Glucose, cholesterol, triglycerides, anion gap, calcium, carbon dioxide, chloride, phosphate, potassium, sodium and BUN. Baseline is defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, within each treatment. Change from Baseline was defined as post-dose visit value minus Baseline value.

Outcome measures

Outcome measures
Measure	Portia (0.3 mg EE/ 0.15 mg LNG) n=17 Participants Participants in period 1 received Portia (0.3 mg of EE and 0.15 mg LNG) QD on Day 1 through Day 10.	Portia (0.3 mg EE/ 0.15 mg LNG)+GSK3640254 Participants in treatment period 2 were co-administered with GSK3640254 200 mg QD along with Portia from Day 11 through Day 21.
Period 2: Change From Baseline in Clinical Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium and BUN Glucose, Day 21	-0.141 Millimoles per liter Standard Deviation 0.2553	—
Period 2: Change From Baseline in Clinical Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium and BUN Glucose, Day 24	0.084 Millimoles per liter Standard Deviation 0.2043	—
Period 2: Change From Baseline in Clinical Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium and BUN Cholesterol, Day 21	-0.161 Millimoles per liter Standard Deviation 0.2891	—
Period 2: Change From Baseline in Clinical Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium and BUN Cholesterol, Day 24	0.075 Millimoles per liter Standard Deviation 0.4580	—
Period 2: Change From Baseline in Clinical Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium and BUN Triglycerides, Day 21	-0.008 Millimoles per liter Standard Deviation 0.1524	—
Period 2: Change From Baseline in Clinical Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium and BUN Triglycerides, Day 24	-0.066 Millimoles per liter Standard Deviation 0.1786	—
Period 2: Change From Baseline in Clinical Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium and BUN Anion gap, Day 21	-1.5 Millimoles per liter Standard Deviation 1.12	—
Period 2: Change From Baseline in Clinical Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium and BUN Anion gap, Day 24	-0.6 Millimoles per liter Standard Deviation 1.80	—
Period 2: Change From Baseline in Clinical Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium and BUN Calcium, Day 21	-0.034 Millimoles per liter Standard Deviation 0.0546	—
Period 2: Change From Baseline in Clinical Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium and BUN Calcium, Day 24	0.000 Millimoles per liter Standard Deviation 0.0643	—
Period 2: Change From Baseline in Clinical Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium and BUN Carbon dioxide, Day 21	0.7 Millimoles per liter Standard Deviation 1.16	—
Period 2: Change From Baseline in Clinical Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium and BUN Carbon dioxide, Day 24	1.6 Millimoles per liter Standard Deviation 0.87	—
Period 2: Change From Baseline in Clinical Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium and BUN Chloride, Day 21	-0.6 Millimoles per liter Standard Deviation 1.06	—
Period 2: Change From Baseline in Clinical Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium and BUN Chloride, Day 24	0.5 Millimoles per liter Standard Deviation 1.33	—
Period 2: Change From Baseline in Clinical Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium and BUN Phosphate, Day 21	-0.074 Millimoles per liter Standard Deviation 0.1073	—
Period 2: Change From Baseline in Clinical Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium and BUN Phosphate, Day 24	-0.064 Millimoles per liter Standard Deviation 0.0878	—
Period 2: Change From Baseline in Clinical Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium and BUN Potassium, Day 21	-0.06 Millimoles per liter Standard Deviation 0.253	—
Period 2: Change From Baseline in Clinical Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium and BUN Potassium, Day 24	-0.02 Millimoles per liter Standard Deviation 0.235	—
Period 2: Change From Baseline in Clinical Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium and BUN Sodium, Day 21	-1.2 Millimoles per liter Standard Deviation 1.03	—
Period 2: Change From Baseline in Clinical Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium and BUN Sodium, Day 24	1.5 Millimoles per liter Standard Deviation 1.66	—
Period 2: Change From Baseline in Clinical Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium and BUN BUN, Day 21	-0.664 Millimoles per liter Standard Deviation 0.5033	—
Period 2: Change From Baseline in Clinical Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium and BUN BUN, Day 24	-0.568 Millimoles per liter Standard Deviation 0.4591	—

SECONDARY outcome

Timeframe: Baseline (Day 1, Pre-dose) and at Day 10

Population: Safety Population.

Blood samples were collected at indicated time points for the analysis of clinical chemistry parameters including plasma albumin, globulin and protein. Baseline is defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, within each treatment. Change from Baseline was defined as post-dose visit value minus Baseline value.

Outcome measures

Outcome measures
Measure	Portia (0.3 mg EE/ 0.15 mg LNG) n=23 Participants Participants in period 1 received Portia (0.3 mg of EE and 0.15 mg LNG) QD on Day 1 through Day 10.	Portia (0.3 mg EE/ 0.15 mg LNG)+GSK3640254 Participants in treatment period 2 were co-administered with GSK3640254 200 mg QD along with Portia from Day 11 through Day 21.
Period 1: Change From Baseline in Clinical Chemistry Parameters: Plasma Albumin, Globulin and Protein Albumin	-0.1 Grams per liter Standard Deviation 1.62	—
Period 1: Change From Baseline in Clinical Chemistry Parameters: Plasma Albumin, Globulin and Protein Globulin	1.0 Grams per liter Standard Deviation 1.60	—
Period 1: Change From Baseline in Clinical Chemistry Parameters: Plasma Albumin, Globulin and Protein Protein	0.9 Grams per liter Standard Deviation 2.94	—

SECONDARY outcome

Timeframe: Baseline (Day 10) and at Days 21 and 24

Population: Safety Population. Only those participants with data available at specified time points were analyzed.

Blood samples were collected at indicated time points for the analysis of clinical chemistry parameters including plasma albumin, globulin and protein. Baseline is defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, within each treatment. Change from Baseline was defined as post-dose visit value minus Baseline value.

Outcome measures

Outcome measures
Measure	Portia (0.3 mg EE/ 0.15 mg LNG) n=17 Participants Participants in period 1 received Portia (0.3 mg of EE and 0.15 mg LNG) QD on Day 1 through Day 10.	Portia (0.3 mg EE/ 0.15 mg LNG)+GSK3640254 Participants in treatment period 2 were co-administered with GSK3640254 200 mg QD along with Portia from Day 11 through Day 21.
Period 2: Change From Baseline in Clinical Chemistry Parameters: Plasma Albumin, Globulin and Protein Protein, Day 24	0.9 Grams per liter Standard Deviation 4.31	—
Period 2: Change From Baseline in Clinical Chemistry Parameters: Plasma Albumin, Globulin and Protein Albumin, Day 21	-0.5 Grams per liter Standard Deviation 1.46	—
Period 2: Change From Baseline in Clinical Chemistry Parameters: Plasma Albumin, Globulin and Protein Albumin, Day 24	0.1 Grams per liter Standard Deviation 2.52	—
Period 2: Change From Baseline in Clinical Chemistry Parameters: Plasma Albumin, Globulin and Protein Globulin, Day 21	-0.4 Grams per liter Standard Deviation 1.54	—
Period 2: Change From Baseline in Clinical Chemistry Parameters: Plasma Albumin, Globulin and Protein Globulin, Day 24	0.8 Grams per liter Standard Deviation 1.91	—
Period 2: Change From Baseline in Clinical Chemistry Parameters: Plasma Albumin, Globulin and Protein Protein, Day 21	-0.9 Grams per liter Standard Deviation 2.73	—

SECONDARY outcome

Timeframe: Baseline (Day 1, Pre-dose) and at Day 10

Population: Safety Population.

Blood samples were collected at indicated time points for the analysis of clinical chemistry parameters including plasma amylase and lipase. Baseline is defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, within each treatment. Change from Baseline was defined as post-dose visit value minus Baseline value.

Outcome measures

Outcome measures
Measure	Portia (0.3 mg EE/ 0.15 mg LNG) n=23 Participants Participants in period 1 received Portia (0.3 mg of EE and 0.15 mg LNG) QD on Day 1 through Day 10.	Portia (0.3 mg EE/ 0.15 mg LNG)+GSK3640254 Participants in treatment period 2 were co-administered with GSK3640254 200 mg QD along with Portia from Day 11 through Day 21.
Period 1: Change From Baseline in Clinical Chemistry Parameters: Plasma Amylase and Lipase Amylase	-0.7 Units per liter Standard Deviation 7.83	—
Period 1: Change From Baseline in Clinical Chemistry Parameters: Plasma Amylase and Lipase Lipase	2.1 Units per liter Standard Deviation 4.03	—

SECONDARY outcome

Timeframe: Baseline (Day 10) and at Days 21 and 24

Population: Safety Population. Only those participants with data available at specified time points were analyzed.

Blood samples were collected at indicated time points for the analysis of clinical chemistry parameters including plasma amylase and lipase. Baseline is defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, within each treatment. Change from Baseline was defined as post-dose visit value minus Baseline value.

Outcome measures

Outcome measures
Measure	Portia (0.3 mg EE/ 0.15 mg LNG) n=17 Participants Participants in period 1 received Portia (0.3 mg of EE and 0.15 mg LNG) QD on Day 1 through Day 10.	Portia (0.3 mg EE/ 0.15 mg LNG)+GSK3640254 Participants in treatment period 2 were co-administered with GSK3640254 200 mg QD along with Portia from Day 11 through Day 21.
Period 2: Change From Baseline in Clinical Chemistry Parameters: Plasma Amylase and Lipase Amylase, Day 21	3.2 Units per liter Standard Deviation 6.03	—
Period 2: Change From Baseline in Clinical Chemistry Parameters: Plasma Amylase and Lipase Amylase, Day 24	5.2 Units per liter Standard Deviation 6.69	—
Period 2: Change From Baseline in Clinical Chemistry Parameters: Plasma Amylase and Lipase Lipase, Day 21	1.8 Units per liter Standard Deviation 3.77	—
Period 2: Change From Baseline in Clinical Chemistry Parameters: Plasma Amylase and Lipase Lipase, Day 24	1.6 Units per liter Standard Deviation 3.33	—

SECONDARY outcome

Timeframe: Baseline (Day 1, Pre-dose) and at Day 10

Population: Safety Population.

Blood samples were collected at indicated time points for the analysis of clinical chemistry parameters including Plasma creatine kinase, lactate dehydrogenase, ALT, ALP, AST and GGT. Baseline is defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, within each treatment. Change from Baseline was defined as post-dose visit value minus Baseline value.

Outcome measures

Outcome measures
Measure	Portia (0.3 mg EE/ 0.15 mg LNG) n=23 Participants Participants in period 1 received Portia (0.3 mg of EE and 0.15 mg LNG) QD on Day 1 through Day 10.	Portia (0.3 mg EE/ 0.15 mg LNG)+GSK3640254 Participants in treatment period 2 were co-administered with GSK3640254 200 mg QD along with Portia from Day 11 through Day 21.
Period 1: Change From Baseline in Clinical Chemistry Parameters: Plasma Creatine Kinase, Lactate Dehydrogenase, Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST) and Gamma Glutamyl Transferase (GGT) Creatine kinase	-3.6 International units per liter Standard Deviation 19.7	—
Period 1: Change From Baseline in Clinical Chemistry Parameters: Plasma Creatine Kinase, Lactate Dehydrogenase, Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST) and Gamma Glutamyl Transferase (GGT) lactate dehydrogenase	0.0 International units per liter Standard Deviation 11.76	—
Period 1: Change From Baseline in Clinical Chemistry Parameters: Plasma Creatine Kinase, Lactate Dehydrogenase, Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST) and Gamma Glutamyl Transferase (GGT) ALT	11.5 International units per liter Standard Deviation 24.80	—
Period 1: Change From Baseline in Clinical Chemistry Parameters: Plasma Creatine Kinase, Lactate Dehydrogenase, Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST) and Gamma Glutamyl Transferase (GGT) ALP	-3.9 International units per liter Standard Deviation 5.89	—
Period 1: Change From Baseline in Clinical Chemistry Parameters: Plasma Creatine Kinase, Lactate Dehydrogenase, Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST) and Gamma Glutamyl Transferase (GGT) AST	3.6 International units per liter Standard Deviation 9.74	—
Period 1: Change From Baseline in Clinical Chemistry Parameters: Plasma Creatine Kinase, Lactate Dehydrogenase, Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST) and Gamma Glutamyl Transferase (GGT) GGT	1.7 International units per liter Standard Deviation 8.36	—

SECONDARY outcome

Timeframe: Baseline (Day 10) and at Days 21 and 24

Population: Safety Population. Only those participants with data available at specified time points were analyzed.

Blood samples were collected at indicated time points for the analysis of clinical chemistry parameters including Plasma creatine kinase, lactate dehydrogenase, ALT, ALP, AST and GGT. Baseline is defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, within each treatment. Change from Baseline was defined as post-dose visit value minus Baseline value.

Outcome measures

Outcome measures
Measure	Portia (0.3 mg EE/ 0.15 mg LNG) n=17 Participants Participants in period 1 received Portia (0.3 mg of EE and 0.15 mg LNG) QD on Day 1 through Day 10.	Portia (0.3 mg EE/ 0.15 mg LNG)+GSK3640254 Participants in treatment period 2 were co-administered with GSK3640254 200 mg QD along with Portia from Day 11 through Day 21.
Period 2: Change From Baseline in Clinical Chemistry Parameters: Plasma Creatine Kinase, Lactate Dehydrogenase, ALT, ALP, AST and GGT Creatine kinase, Day 21	-1.6 Units per liter Standard Deviation 9.51	—
Period 2: Change From Baseline in Clinical Chemistry Parameters: Plasma Creatine Kinase, Lactate Dehydrogenase, ALT, ALP, AST and GGT Creatine kinase, Day 24	-1.7 Units per liter Standard Deviation 12.18	—
Period 2: Change From Baseline in Clinical Chemistry Parameters: Plasma Creatine Kinase, Lactate Dehydrogenase, ALT, ALP, AST and GGT Lactate dehydrogenase, Day 21	4.2 Units per liter Standard Deviation 10.61	—
Period 2: Change From Baseline in Clinical Chemistry Parameters: Plasma Creatine Kinase, Lactate Dehydrogenase, ALT, ALP, AST and GGT Lactate dehydrogenase, Day 24	8.4 Units per liter Standard Deviation 16.00	—
Period 2: Change From Baseline in Clinical Chemistry Parameters: Plasma Creatine Kinase, Lactate Dehydrogenase, ALT, ALP, AST and GGT ALT, Day 21	25.7 Units per liter Standard Deviation 24.80	—
Period 2: Change From Baseline in Clinical Chemistry Parameters: Plasma Creatine Kinase, Lactate Dehydrogenase, ALT, ALP, AST and GGT ALT, Day 24	34.5 Units per liter Standard Deviation 37.36	—
Period 2: Change From Baseline in Clinical Chemistry Parameters: Plasma Creatine Kinase, Lactate Dehydrogenase, ALT, ALP, AST and GGT ALP, Day 21	-1.1 Units per liter Standard Deviation 2.38	—
Period 2: Change From Baseline in Clinical Chemistry Parameters: Plasma Creatine Kinase, Lactate Dehydrogenase, ALT, ALP, AST and GGT ALP, Day 24	-1.9 Units per liter Standard Deviation 3.60	—
Period 2: Change From Baseline in Clinical Chemistry Parameters: Plasma Creatine Kinase, Lactate Dehydrogenase, ALT, ALP, AST and GGT AST, Day 21	10.1 Units per liter Standard Deviation 9.97	—
Period 2: Change From Baseline in Clinical Chemistry Parameters: Plasma Creatine Kinase, Lactate Dehydrogenase, ALT, ALP, AST and GGT AST, Day 24	12.6 Units per liter Standard Deviation 15.62	—
Period 2: Change From Baseline in Clinical Chemistry Parameters: Plasma Creatine Kinase, Lactate Dehydrogenase, ALT, ALP, AST and GGT GGT, Day 21	0.0 Units per liter Standard Deviation 1.73	—
Period 2: Change From Baseline in Clinical Chemistry Parameters: Plasma Creatine Kinase, Lactate Dehydrogenase, ALT, ALP, AST and GGT GGT, Day 24	0.1 Units per liter Standard Deviation 1.60	—

SECONDARY outcome

Timeframe: Baseline (Day 1, Pre-dose) and at Day 10

Population: Safety Population.

Blood samples were collected at indicated time points for the analysis of clinical chemistry parameters including Plasma urate, creatinine, total bilirubin and direct bilirubin. Baseline is defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, within each treatment. Change from Baseline was defined as post-dose visit value minus Baseline value.

Outcome measures

Outcome measures
Measure	Portia (0.3 mg EE/ 0.15 mg LNG) n=23 Participants Participants in period 1 received Portia (0.3 mg of EE and 0.15 mg LNG) QD on Day 1 through Day 10.	Portia (0.3 mg EE/ 0.15 mg LNG)+GSK3640254 Participants in treatment period 2 were co-administered with GSK3640254 200 mg QD along with Portia from Day 11 through Day 21.
Period 1: Change From Baseline in Clinical Chemistry Parameters: Plasma Urate, Creatinine, Total Bilirubin and Direct Bilirubin Urate	-18.0 Micromoles per liter Standard Deviation 19.09	—
Period 1: Change From Baseline in Clinical Chemistry Parameters: Plasma Urate, Creatinine, Total Bilirubin and Direct Bilirubin Creatinine	0.93 Micromoles per liter Standard Deviation 3.079	—
Period 1: Change From Baseline in Clinical Chemistry Parameters: Plasma Urate, Creatinine, Total Bilirubin and Direct Bilirubin Total bilirubin	-0.57 Micromoles per liter Standard Deviation 1.638	—
Period 1: Change From Baseline in Clinical Chemistry Parameters: Plasma Urate, Creatinine, Total Bilirubin and Direct Bilirubin Direct bilirubin	-0.21 Micromoles per liter Standard Deviation 0.467	—

SECONDARY outcome

Timeframe: Baseline (Day 10) and at Days 21 and 24

Population: Safety Population. Only those participants with data available at specified time points were analyzed.

Blood samples were collected at indicated time points for the analysis of clinical chemistry parameters including Plasma urate, creatinine, total bilirubin and direct bilirubin. Baseline is defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, within each treatment. Change from Baseline was defined as post-dose visit value minus Baseline value.

Outcome measures

Outcome measures
Measure	Portia (0.3 mg EE/ 0.15 mg LNG) n=17 Participants Participants in period 1 received Portia (0.3 mg of EE and 0.15 mg LNG) QD on Day 1 through Day 10.	Portia (0.3 mg EE/ 0.15 mg LNG)+GSK3640254 Participants in treatment period 2 were co-administered with GSK3640254 200 mg QD along with Portia from Day 11 through Day 21.
Period 2: Change From Baseline in Clinical Chemistry Parameters: Plasma Urate, Creatinine, Total Bilirubin and Direct Bilirubin Urate, Day 21	-45.2 Micromoles per liter Standard Deviation 19.22	—
Period 2: Change From Baseline in Clinical Chemistry Parameters: Plasma Urate, Creatinine, Total Bilirubin and Direct Bilirubin Urate, Day 24	-34.7 Micromoles per liter Standard Deviation 19.63	—
Period 2: Change From Baseline in Clinical Chemistry Parameters: Plasma Urate, Creatinine, Total Bilirubin and Direct Bilirubin Creatinine, Day 21	0.52 Micromoles per liter Standard Deviation 2.852	—
Period 2: Change From Baseline in Clinical Chemistry Parameters: Plasma Urate, Creatinine, Total Bilirubin and Direct Bilirubin Creatinine, Day 24	1.29 Micromoles per liter Standard Deviation 3.013	—
Period 2: Change From Baseline in Clinical Chemistry Parameters: Plasma Urate, Creatinine, Total Bilirubin and Direct Bilirubin Total bilirubin, Day 21	0.08 Micromoles per liter Standard Deviation 1.000	—
Period 2: Change From Baseline in Clinical Chemistry Parameters: Plasma Urate, Creatinine, Total Bilirubin and Direct Bilirubin Total bilirubin, Day 24	0.12 Micromoles per liter Standard Deviation 1.177	—
Period 2: Change From Baseline in Clinical Chemistry Parameters: Plasma Urate, Creatinine, Total Bilirubin and Direct Bilirubin Direct bilirubin, Day 21	0.07 Micromoles per liter Standard Deviation 0.214	—
Period 2: Change From Baseline in Clinical Chemistry Parameters: Plasma Urate, Creatinine, Total Bilirubin and Direct Bilirubin Direct bilirubin, Day 24	0.15 Micromoles per liter Standard Deviation 0.318	—

SECONDARY outcome

Timeframe: Baseline (Day 1, Pre-dose) and at Day 10

Population: Safety Population.

Blood samples were collected at indicated time points for the analysis of hematology parameters including Basophils, eosinophils, leukocytes, lymphocytes, monocytes, neutrophils and platelets. Baseline is defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, within each treatment. Change from Baseline was defined as post-dose visit value minus Baseline value.

Outcome measures

Outcome measures
Measure	Portia (0.3 mg EE/ 0.15 mg LNG) n=23 Participants Participants in period 1 received Portia (0.3 mg of EE and 0.15 mg LNG) QD on Day 1 through Day 10.	Portia (0.3 mg EE/ 0.15 mg LNG)+GSK3640254 Participants in treatment period 2 were co-administered with GSK3640254 200 mg QD along with Portia from Day 11 through Day 21.
Period 1: Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets Basophils	0.000 10^9 cells per liter Standard Deviation 0.0133	—
Period 1: Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets Eosinophils	0.008 10^9 cells per liter Standard Deviation 0.0263	—
Period 1: Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets Leukocytes	-0.02 10^9 cells per liter Standard Deviation 0.867	—
Period 1: Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets Lymphocytes	0.086 10^9 cells per liter Standard Deviation 0.2168	—
Period 1: Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets Monocytes	-0.012 10^9 cells per liter Standard Deviation 0.0760	—
Period 1: Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets Neutrophils	-0.103 10^9 cells per liter Standard Deviation 0.7505	—
Period 1: Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets Platelets	-1.6 10^9 cells per liter Standard Deviation 32.32	—

SECONDARY outcome

Timeframe: Baseline (Day 10) and at Days 21 and 24

Population: Safety Population. Only those participants with data available at specified time points were analyzed.

Blood samples were collected at indicated time points for the analysis of hematology parameters including Basophils, eosinophils, leukocytes, lymphocytes, monocytes, neutrophils and platelets. Baseline is defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, within each treatment. Change from Baseline was defined as post-dose visit value minus Baseline value.

Outcome measures

Outcome measures
Measure	Portia (0.3 mg EE/ 0.15 mg LNG) n=17 Participants Participants in period 1 received Portia (0.3 mg of EE and 0.15 mg LNG) QD on Day 1 through Day 10.	Portia (0.3 mg EE/ 0.15 mg LNG)+GSK3640254 Participants in treatment period 2 were co-administered with GSK3640254 200 mg QD along with Portia from Day 11 through Day 21.
Period 2: Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets Basophils, Day 21	0.001 10^9 cells per liter Standard Deviation 0.0130	—
Period 2: Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets Basophils, Day 24	0.000 10^9 cells per liter Standard Deviation 0.0150	—
Period 2: Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets Eosinophils, Day 21	0.001 10^9 cells per liter Standard Deviation 0.0209	—
Period 2: Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets Eosinophils, Day 24	-0.005 10^9 cells per liter Standard Deviation 0.0414	—
Period 2: Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets Leukocytes, Day 21	-0.43 10^9 cells per liter Standard Deviation 0.905	—
Period 2: Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets Leukocytes, Day 24	-0.88 10^9 cells per liter Standard Deviation 0.901	—
Period 2: Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets Lymphocytes, Day 21	-0.095 10^9 cells per liter Standard Deviation 0.2468	—
Period 2: Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets Lymphocytes, Day 24	-0.101 10^9 cells per liter Standard Deviation 0.1617	—
Period 2: Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets Monocytes, Day 21	-0.045 10^9 cells per liter Standard Deviation 0.0609	—
Period 2: Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets Monocytes, Day 24	-0.064 10^9 cells per liter Standard Deviation 0.0676	—
Period 2: Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets Neutrophils, Day 21	-0.285 10^9 cells per liter Standard Deviation 0.7448	—
Period 2: Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets Neutrophils, Day 24	-0.708 10^9 cells per liter Standard Deviation 0.7253	—
Period 2: Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets Platelets, Day 21	12.2 10^9 cells per liter Standard Deviation 31.07	—
Period 2: Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets Platelets, Day 24	6.8 10^9 cells per liter Standard Deviation 27.18	—

SECONDARY outcome

Timeframe: Baseline (Day 1, Pre-dose) and at Day 10

Population: Safety Population.

Blood samples were collected at indicated time points for the analysis of hematology parameter erythrocytes mean corpuscular hemoglobin. Baseline is defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, within each treatment. Change from Baseline was defined as post-dose visit value minus Baseline value.

Outcome measures

Outcome measures
Measure	Portia (0.3 mg EE/ 0.15 mg LNG) n=23 Participants Participants in period 1 received Portia (0.3 mg of EE and 0.15 mg LNG) QD on Day 1 through Day 10.	Portia (0.3 mg EE/ 0.15 mg LNG)+GSK3640254 Participants in treatment period 2 were co-administered with GSK3640254 200 mg QD along with Portia from Day 11 through Day 21.
Period 1: Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Hemoglobin	-0.09 Picograms Standard Deviation 0.366	—

SECONDARY outcome

Timeframe: Baseline (Day 10) and at Days 21 and 24

Population: Safety Population. Only those participants with data available at specified time points were analyzed.

Blood samples were collected at indicated time points for the analysis of hematology parameter erythrocytes mean corpuscular hemoglobin. Baseline is defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, within each treatment. Change from Baseline was defined as post-dose visit value minus Baseline value.

Outcome measures

Outcome measures
Measure	Portia (0.3 mg EE/ 0.15 mg LNG) n=17 Participants Participants in period 1 received Portia (0.3 mg of EE and 0.15 mg LNG) QD on Day 1 through Day 10.	Portia (0.3 mg EE/ 0.15 mg LNG)+GSK3640254 Participants in treatment period 2 were co-administered with GSK3640254 200 mg QD along with Portia from Day 11 through Day 21.
Period 2: Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Hemoglobin Day 24	-0.10 Picograms Standard Deviation 0.377	—
Period 2: Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Hemoglobin Day 21	-0.51 Picograms Standard Deviation 0.394	—

SECONDARY outcome

Timeframe: Baseline (Day 1, Pre-dose) and at Day 10

Population: Safety Population.

Blood samples were collected at indicated time points for the analysis of hematology parameter erythrocytes mean corpuscular volume. Baseline is defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, within each treatment. Change from Baseline was defined as post-dose visit value minus Baseline value.

Outcome measures

Outcome measures
Measure	Portia (0.3 mg EE/ 0.15 mg LNG) n=23 Participants Participants in period 1 received Portia (0.3 mg of EE and 0.15 mg LNG) QD on Day 1 through Day 10.	Portia (0.3 mg EE/ 0.15 mg LNG)+GSK3640254 Participants in treatment period 2 were co-administered with GSK3640254 200 mg QD along with Portia from Day 11 through Day 21.
Period 1: Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Volume	-0.18 Femtoliters Standard Deviation 0.657	—

SECONDARY outcome

Timeframe: Baseline (Day 10) and at Days 21 and 24

Population: Safety Population. Only those participants with data available at specified time points were analyzed.

Blood samples were collected at indicated time points for the analysis of hematology parameter erythrocytes mean corpuscular volume. Baseline is defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, within each treatment. Change from Baseline was defined as post-dose visit value minus Baseline value.

Outcome measures

Outcome measures
Measure	Portia (0.3 mg EE/ 0.15 mg LNG) n=17 Participants Participants in period 1 received Portia (0.3 mg of EE and 0.15 mg LNG) QD on Day 1 through Day 10.	Portia (0.3 mg EE/ 0.15 mg LNG)+GSK3640254 Participants in treatment period 2 were co-administered with GSK3640254 200 mg QD along with Portia from Day 11 through Day 21.
Period 2: Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Volume Day 21	-0.50 Femtoliters Standard Deviation 0.516	—
Period 2: Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Volume Day 24	0.04 Femtoliters Standard Deviation 0.818	—

SECONDARY outcome

Timeframe: Baseline (Day 1, Pre-dose) and at Day 10

Population: Safety Population.

Blood samples were collected at indicated time points for the analysis of hematology parameter erythrocytes. Baseline is defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, within each treatment. Change from Baseline was defined as post-dose visit value minus Baseline value.

Outcome measures

Outcome measures
Measure	Portia (0.3 mg EE/ 0.15 mg LNG) n=23 Participants Participants in period 1 received Portia (0.3 mg of EE and 0.15 mg LNG) QD on Day 1 through Day 10.	Portia (0.3 mg EE/ 0.15 mg LNG)+GSK3640254 Participants in treatment period 2 were co-administered with GSK3640254 200 mg QD along with Portia from Day 11 through Day 21.
Period 1: Change From Baseline in Hematology Parameter: Erythrocytes	-0.010 10^12 cells per liter Standard Deviation 0.1287	—

SECONDARY outcome

Timeframe: Baseline (Day 10) and at Days 21 and 24

Population: Safety Population. Only those participants with data available at specified time points were analyzed.

Blood samples were collected at indicated time points for the analysis of hematology parameter erythrocytes. Baseline is defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, within each treatment. Change from Baseline was defined as post-dose visit value minus Baseline value.

Outcome measures

Outcome measures
Measure	Portia (0.3 mg EE/ 0.15 mg LNG) n=17 Participants Participants in period 1 received Portia (0.3 mg of EE and 0.15 mg LNG) QD on Day 1 through Day 10.	Portia (0.3 mg EE/ 0.15 mg LNG)+GSK3640254 Participants in treatment period 2 were co-administered with GSK3640254 200 mg QD along with Portia from Day 11 through Day 21.
Period 2: Change From Baseline in Hematology Parameter: Erythrocytes Day 21	0.106 10^12 cells per liter Standard Deviation 0.1093	—
Period 2: Change From Baseline in Hematology Parameter: Erythrocytes Day 24	0.134 10^12 cells per liter Standard Deviation 0.1675	—

SECONDARY outcome

Timeframe: Baseline (Day 1, Pre-dose) and at Day 10

Population: Safety Population.

Blood samples were collected at indicated time points for the analysis of hematology parameter hematocrit. Baseline is defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, within each treatment. Change from Baseline was defined as post-dose visit value minus Baseline value.

Outcome measures

Outcome measures
Measure	Portia (0.3 mg EE/ 0.15 mg LNG) n=23 Participants Participants in period 1 received Portia (0.3 mg of EE and 0.15 mg LNG) QD on Day 1 through Day 10.	Portia (0.3 mg EE/ 0.15 mg LNG)+GSK3640254 Participants in treatment period 2 were co-administered with GSK3640254 200 mg QD along with Portia from Day 11 through Day 21.
Period 1: Change From Baseline in Hematology Parameter: Hematocrit	-0.0014 Proportion of red blood cells in blood Standard Deviation 0.01165	—

SECONDARY outcome

Timeframe: Baseline (Day 10) and at Days 21 and 24

Population: Safety Population. Only those participants with data available at specified time points were analyzed.

Blood samples were collected at indicated time points for the analysis of hematology parameter hematocrit. Baseline is defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, within each treatment. Change from Baseline was defined as post-dose visit value minus Baseline value.

Outcome measures

Outcome measures
Measure	Portia (0.3 mg EE/ 0.15 mg LNG) n=17 Participants Participants in period 1 received Portia (0.3 mg of EE and 0.15 mg LNG) QD on Day 1 through Day 10.	Portia (0.3 mg EE/ 0.15 mg LNG)+GSK3640254 Participants in treatment period 2 were co-administered with GSK3640254 200 mg QD along with Portia from Day 11 through Day 21.
Period 2: Change From Baseline in Hematology Parameter: Hematocrit Day 21	0.0071 Proportion of red blood cells in blood Standard Deviation 0.01046	—
Period 2: Change From Baseline in Hematology Parameter: Hematocrit Day 24	0.0118 Proportion of red blood cells in blood Standard Deviation 0.01711	—

SECONDARY outcome

Timeframe: Baseline (Day 1, Pre-dose) and at Day 10

Population: Safety Population.

Blood samples were collected at indicated time points for the analysis of hematology parameter hemoglobin. Baseline is defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, within each treatment. Change from Baseline was defined as post-dose visit value minus Baseline value.

Outcome measures

Outcome measures
Measure	Portia (0.3 mg EE/ 0.15 mg LNG) n=23 Participants Participants in period 1 received Portia (0.3 mg of EE and 0.15 mg LNG) QD on Day 1 through Day 10.	Portia (0.3 mg EE/ 0.15 mg LNG)+GSK3640254 Participants in treatment period 2 were co-administered with GSK3640254 200 mg QD along with Portia from Day 11 through Day 21.
Period 1: Change From Baseline in Hematology Parameter: Hemoglobin	-0.7 Grams per liter Standard Deviation 3.74	—

SECONDARY outcome

Timeframe: Baseline (Day 10) and at Days 21 and 24

Population: Safety Population. Only those participants with data available at specified time points were analyzed.

Blood samples were collected at indicated time points for the analysis of hematology parameter hemoglobin. Baseline is defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, within each treatment. Change from Baseline was defined as post-dose visit value minus Baseline value.

Outcome measures

Outcome measures
Measure	Portia (0.3 mg EE/ 0.15 mg LNG) n=17 Participants Participants in period 1 received Portia (0.3 mg of EE and 0.15 mg LNG) QD on Day 1 through Day 10.	Portia (0.3 mg EE/ 0.15 mg LNG)+GSK3640254 Participants in treatment period 2 were co-administered with GSK3640254 200 mg QD along with Portia from Day 11 through Day 21.
Period 2: Change From Baseline in Hematology Parameter: Hemoglobin Day 24	3.8 Grams per liter Standard Deviation 5.45	—
Period 2: Change From Baseline in Hematology Parameter: Hemoglobin Day 21	1.2 Grams per liter Standard Deviation 3.63	—

SECONDARY outcome

Timeframe: Baseline (Day 1, Pre-dose) and at Day 10

Population: Safety Population.

Urine samples were collected at indicated time points for the assessment of specific gravity. Urine specific gravity is a measure of the concentration of solutes in the urine and provides information on the kidney's ability to concentrate urine. The concentration of the excreted molecules determines the urine's specific gravity. Baseline is defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, within each treatment. Change from Baseline was defined as post-dose visit value minus Baseline value.

Outcome measures

Outcome measures
Measure	Portia (0.3 mg EE/ 0.15 mg LNG) n=23 Participants Participants in period 1 received Portia (0.3 mg of EE and 0.15 mg LNG) QD on Day 1 through Day 10.	Portia (0.3 mg EE/ 0.15 mg LNG)+GSK3640254 Participants in treatment period 2 were co-administered with GSK3640254 200 mg QD along with Portia from Day 11 through Day 21.
Period 1: Change From Baseline in Urine Concentration: Urine Specific Gravity	0.0023 Ratio Standard Deviation 0.00922	—

SECONDARY outcome

Timeframe: Baseline (Day 10) and at Days 21 and 24

Population: Safety Population. Only those participants with data available at specified time points were analyzed (represented by n=X in the category titles).

Urine samples were collected at indicated time points for the assessment of specific gravity. Urine specific gravity is a measure of the concentration of solutes in the urine and provides information on the kidney's ability to concentrate urine. The concentration of the excreted molecules determines the urine's specific gravity. Baseline is defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, within each treatment. Change from Baseline was defined as post-dose visit value minus Baseline value.

Outcome measures

Outcome measures
Measure	Portia (0.3 mg EE/ 0.15 mg LNG) n=21 Participants Participants in period 1 received Portia (0.3 mg of EE and 0.15 mg LNG) QD on Day 1 through Day 10.	Portia (0.3 mg EE/ 0.15 mg LNG)+GSK3640254 Participants in treatment period 2 were co-administered with GSK3640254 200 mg QD along with Portia from Day 11 through Day 21.
Period 2: Change From Baseline in Urine Concentration: Urine Specific Gravity Day 21, n=18	-0.0028 Ratio Standard Deviation 0.01150	—
Period 2: Change From Baseline in Urine Concentration: Urine Specific Gravity Day 24, n=17	-0.0021 Ratio Standard Deviation 0.00888	—

SECONDARY outcome

Timeframe: Baseline (Day 1, Pre-dose) and at Day 10

Population: Safety Population.

Urine samples were collected at indicated time points for the assessment of urine urobilinogen. Baseline is defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, within each treatment. Change from Baseline was defined as post-dose visit value minus Baseline value.

Outcome measures

Outcome measures
Measure	Portia (0.3 mg EE/ 0.15 mg LNG) n=23 Participants Participants in period 1 received Portia (0.3 mg of EE and 0.15 mg LNG) QD on Day 1 through Day 10.	Portia (0.3 mg EE/ 0.15 mg LNG)+GSK3640254 Participants in treatment period 2 were co-administered with GSK3640254 200 mg QD along with Portia from Day 11 through Day 21.
Period 1: Change From Baseline in Urine Concentration: Urine Urobilinogen	1.7666 Micromoles per liter Standard Deviation 4.66388	—

SECONDARY outcome

Timeframe: Baseline (Day 10) and at Days 21 and 24

Population: Safety Population. Only those participants with data available at specified time points were analyzed (represented by n=X in the category titles).

Urine samples were collected at indicated time points for the assessment of urine urobilinogen. Baseline is defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, within each treatment. Change from Baseline was defined as post-dose visit value minus Baseline value.

Outcome measures

Outcome measures
Measure	Portia (0.3 mg EE/ 0.15 mg LNG) n=21 Participants Participants in period 1 received Portia (0.3 mg of EE and 0.15 mg LNG) QD on Day 1 through Day 10.	Portia (0.3 mg EE/ 0.15 mg LNG)+GSK3640254 Participants in treatment period 2 were co-administered with GSK3640254 200 mg QD along with Portia from Day 11 through Day 21.
Period 2: Change From Baseline in Urine Concentration: Urine Urobilinogen Day 21, n=18	3.0098 Micromoles per liter Standard Deviation 5.79402	—
Period 2: Change From Baseline in Urine Concentration: Urine Urobilinogen Day 24, n=17	0.0000 Micromoles per liter Standard Deviation 4.78853	—

SECONDARY outcome

Timeframe: Baseline (Day 1, Pre-dose) and at Day 10

Population: Safety Population.

Urine samples were collected at indicated time points for the assessment of Urinary pH. Urine pH is an acid-base measurement. pH is measured on a numeric scale ranging from 0 to 14; values on the scale refer to the degree of alkalinity or acidity. A pH of 7 is neutral. A pH less than 7 is acidic, and a pH greater than 7 is basic. Normal urine has a slightly acid pH (5.0 - 6.0). Baseline is defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, within each treatment. Change from Baseline was defined as post-dose visit value minus Baseline value.

Outcome measures

Outcome measures
Measure	Portia (0.3 mg EE/ 0.15 mg LNG) n=23 Participants Participants in period 1 received Portia (0.3 mg of EE and 0.15 mg LNG) QD on Day 1 through Day 10.	Portia (0.3 mg EE/ 0.15 mg LNG)+GSK3640254 Participants in treatment period 2 were co-administered with GSK3640254 200 mg QD along with Portia from Day 11 through Day 21.
Period 1: Change From Baseline in Urine Concentration: Urine Potential of Hydrogen (pH)	-0.22 pH Standard Deviation 0.473	—

SECONDARY outcome

Timeframe: Baseline (Day 10) and at Days 21 and 24

Population: Safety Population. Only those participants with data available at specified time points were analyzed (represented by n=X in the category titles).

Urine samples were collected at indicated time points for the assessment of Urinary pH. Urine pH is an acid-base measurement. pH is measured on a numeric scale ranging from 0 to 14; values on the scale refer to the degree of alkalinity or acidity. A pH of 7 is neutral. A pH less than 7 is acidic, and a pH greater than 7 is basic. Normal urine has a slightly acid pH (5.0 - 6.0). Baseline is defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, within each treatment. Change from Baseline was defined as post-dose visit value minus Baseline value.

Outcome measures

Outcome measures
Measure	Portia (0.3 mg EE/ 0.15 mg LNG) n=21 Participants Participants in period 1 received Portia (0.3 mg of EE and 0.15 mg LNG) QD on Day 1 through Day 10.	Portia (0.3 mg EE/ 0.15 mg LNG)+GSK3640254 Participants in treatment period 2 were co-administered with GSK3640254 200 mg QD along with Portia from Day 11 through Day 21.
Period 2: Change From Baseline in Urine Concentration: Urine pH Day 21, n=18	0.39 pH Standard Deviation 0.583	—
Period 2: Change From Baseline in Urine Concentration: Urine pH Day 24, n=17	0.24 pH Standard Deviation 0.400	—

SECONDARY outcome

Timeframe: Baseline (Day 1, Pre-dose) and at Day 10

Population: Safety Population.

Twelve-lead ECGs were performed with the participant in a supine or semi-supine position after a rest of at least 10 minutes using an automated ECG machine to measure heart rate. Baseline is defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, within each treatment. Change from Baseline was defined as post-dose visit value minus Baseline value.

Outcome measures

Outcome measures
Measure	Portia (0.3 mg EE/ 0.15 mg LNG) n=23 Participants Participants in period 1 received Portia (0.3 mg of EE and 0.15 mg LNG) QD on Day 1 through Day 10.	Portia (0.3 mg EE/ 0.15 mg LNG)+GSK3640254 Participants in treatment period 2 were co-administered with GSK3640254 200 mg QD along with Portia from Day 11 through Day 21.
Period 1: Change From Baseline in Electrocardiogram (ECG) Mean Heart Rate	-0.8 Beats per minute Standard Deviation 5.95	—

SECONDARY outcome

Timeframe: Baseline (Day 11, Pre-dose) and at Day 11: 2, 4, 6 hours, Day 15: 2, 4, 6 hours, Day 21 and 24

Population: Safety Population. Only those participants with data available at specified time points were analyzed (represented by n=X in the category titles).

Twelve-lead ECGs were performed with the participant in a supine or semi-supine position after a rest of at least 10 minutes using an automated ECG machine to measure heart rate. Baseline is defined as the average of the triplicate predose assessments on Day 11. Change from Baseline was defined as post-dose visit value minus Baseline value.

Outcome measures

Outcome measures
Measure	Portia (0.3 mg EE/ 0.15 mg LNG) n=21 Participants Participants in period 1 received Portia (0.3 mg of EE and 0.15 mg LNG) QD on Day 1 through Day 10.	Portia (0.3 mg EE/ 0.15 mg LNG)+GSK3640254 Participants in treatment period 2 were co-administered with GSK3640254 200 mg QD along with Portia from Day 11 through Day 21.
Period 2: Change From Baseline in ECG Mean Heart Rate Day 11: 2 hours, n=21	2.8 Beats per minute Standard Deviation 5.17	—
Period 2: Change From Baseline in ECG Mean Heart Rate Day 11: 4 hours, n=21	-0.6 Beats per minute Standard Deviation 4.79	—
Period 2: Change From Baseline in ECG Mean Heart Rate Day 11: 6 hours, n=21	6.7 Beats per minute Standard Deviation 5.44	—
Period 2: Change From Baseline in ECG Mean Heart Rate Day 15: 2 hours, n=18	3.8 Beats per minute Standard Deviation 6.23	—
Period 2: Change From Baseline in ECG Mean Heart Rate Day 15: 4 hours, n=18	1.7 Beats per minute Standard Deviation 8.01	—
Period 2: Change From Baseline in ECG Mean Heart Rate Day 15: 6 hours, n=18	3.1 Beats per minute Standard Deviation 7.10	—
Period 2: Change From Baseline in ECG Mean Heart Rate Day 21, n=18	3.7 Beats per minute Standard Deviation 6.24	—
Period 2: Change From Baseline in ECG Mean Heart Rate Day 24, n=17	0.6 Beats per minute Standard Deviation 4.42	—

SECONDARY outcome

Timeframe: Baseline (Day 1, Pre-dose) and at Day 10

Population: Safety Population.

Twelve-lead ECGs were performed with the participant in a supine or semi-supine position after a rest of at least 10 minutes using an automated ECG machine to measure PR interval, QRS duration, QT Interval, QTcF Interval and QTcB interval. Baseline is defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, within each treatment. Change from Baseline was defined as post-dose visit value minus Baseline value.

Outcome measures

Outcome measures
Measure	Portia (0.3 mg EE/ 0.15 mg LNG) n=23 Participants Participants in period 1 received Portia (0.3 mg of EE and 0.15 mg LNG) QD on Day 1 through Day 10.	Portia (0.3 mg EE/ 0.15 mg LNG)+GSK3640254 Participants in treatment period 2 were co-administered with GSK3640254 200 mg QD along with Portia from Day 11 through Day 21.
Period 1: Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval, Fridericia QT Correction Formula (QTcF) Interval, and Bazett QT Correction Formula (QTcB) Interval PR interval	2.5 Milliseconds Standard Deviation 8.65	—
Period 1: Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval, Fridericia QT Correction Formula (QTcF) Interval, and Bazett QT Correction Formula (QTcB) Interval QRS duration	0.2 Milliseconds Standard Deviation 5.01	—
Period 1: Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval, Fridericia QT Correction Formula (QTcF) Interval, and Bazett QT Correction Formula (QTcB) Interval QT interval	-3.0 Milliseconds Standard Deviation 11.32	—
Period 1: Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval, Fridericia QT Correction Formula (QTcF) Interval, and Bazett QT Correction Formula (QTcB) Interval QTcF interval	-4.1 Milliseconds Standard Deviation 8.18	—
Period 1: Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval, Fridericia QT Correction Formula (QTcF) Interval, and Bazett QT Correction Formula (QTcB) Interval QTcB interval	-4.6 Milliseconds Standard Deviation 11.80	—

SECONDARY outcome

Timeframe: Baseline (Day 11, Pre-dose) and at Day 11: 2, 4, 6 hours, Day 15: 2, 4, 6 hours, Day 21 and 24

Population: Safety Population. Only those participants with data available at specified time points were analyzed (represented by n=X in the category titles).

Twelve-lead ECGs were performed with the participant in a supine or semi-supine position after a rest of at least 10 minutes using an automated ECG machine to measure heart rate. Baseline is defined as the average of the triplicate predose assessments on Day 11. Change from Baseline was defined as post-dose visit value minus Baseline value.

Outcome measures

Outcome measures
Measure	Portia (0.3 mg EE/ 0.15 mg LNG) n=21 Participants Participants in period 1 received Portia (0.3 mg of EE and 0.15 mg LNG) QD on Day 1 through Day 10.	Portia (0.3 mg EE/ 0.15 mg LNG)+GSK3640254 Participants in treatment period 2 were co-administered with GSK3640254 200 mg QD along with Portia from Day 11 through Day 21.
Period 2: Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF and QTcB Interval PR interval, Day 11: 2 hours, n=21	0.3 Milliseconds Standard Deviation 7.99	—
Period 2: Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF and QTcB Interval PR interval, Day 11: 4 hours, n=21	1.9 Milliseconds Standard Deviation 8.68	—
Period 2: Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF and QTcB Interval PR interval, Day 11: 6 hours, n=21	-1.9 Milliseconds Standard Deviation 9.45	—
Period 2: Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF and QTcB Interval PR interval, Day 15: 2 hours, n=18	-1.7 Milliseconds Standard Deviation 11.37	—
Period 2: Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF and QTcB Interval PR interval, Day 15: 4 hours, n=18	-0.6 Milliseconds Standard Deviation 10.03	—
Period 2: Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF and QTcB Interval PR interval, Day 15: 6 hours, n=18	-2.3 Milliseconds Standard Deviation 7.99	—
Period 2: Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF and QTcB Interval PR interval, Day 21, n=18	1.7 Milliseconds Standard Deviation 7.37	—
Period 2: Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF and QTcB Interval PR interval, Day 24, n=17	2.1 Milliseconds Standard Deviation 7.89	—
Period 2: Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF and QTcB Interval QRS duration, Day 11: 2 hours, n=21	-2.2 Milliseconds Standard Deviation 3.78	—
Period 2: Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF and QTcB Interval QRS duration, Day 11: 4 hours, n=21	-0.7 Milliseconds Standard Deviation 4.51	—
Period 2: Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF and QTcB Interval QRS duration, Day 11: 6 hours, n=21	-0.3 Milliseconds Standard Deviation 4.33	—
Period 2: Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF and QTcB Interval QRS duration, Day 15: 2 hours, n=18	0.2 Milliseconds Standard Deviation 3.78	—
Period 2: Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF and QTcB Interval QRS duration, Day 15: 4 hours, n=18	0.1 Milliseconds Standard Deviation 3.39	—
Period 2: Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF and QTcB Interval QRS duration, Day 15: 6 hours, n=18	-0.9 Milliseconds Standard Deviation 3.02	—
Period 2: Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF and QTcB Interval QRS duration, Day 21, n=18	-0.4 Milliseconds Standard Deviation 4.37	—
Period 2: Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF and QTcB Interval QRS duration, Day 24, n=17	-0.4 Milliseconds Standard Deviation 3.36	—
Period 2: Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF and QTcB Interval QT interval, Day 11: 2 hours, n=21	-16.4 Milliseconds Standard Deviation 8.23	—
Period 2: Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF and QTcB Interval QT interval, Day 11: 4 hours, n=21	2.3 Milliseconds Standard Deviation 10.78	—
Period 2: Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF and QTcB Interval QT interval, Day 11: 6 hours, n=21	-11.7 Milliseconds Standard Deviation 10.22	—
Period 2: Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF and QTcB Interval QT interval, Day 15: 2 hours, n=18	-10.3 Milliseconds Standard Deviation 10.09	—
Period 2: Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF and QTcB Interval QT interval, Day 15: 4 hours, n=18	-0.4 Milliseconds Standard Deviation 15.78	—
Period 2: Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF and QTcB Interval QT interval, Day 15: 6 hours, n=18	2.2 Milliseconds Standard Deviation 14.21	—
Period 2: Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF and QTcB Interval QT interval, Day 21, n=18	-7.4 Milliseconds Standard Deviation 13.77	—
Period 2: Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF and QTcB Interval QT interval, Day 24, n=17	0.1 Milliseconds Standard Deviation 10.06	—
Period 2: Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF and QTcB Interval QTcF interval, Day 11: 2 hours, n=21	-11.5 Milliseconds Standard Deviation 8.78	—
Period 2: Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF and QTcB Interval QTcF interval, Day 11: 4 hours, n=21	1.4 Milliseconds Standard Deviation 8.61	—
Period 2: Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF and QTcB Interval QTcF interval, Day 11: 6 hours, n=21	1.3 Milliseconds Standard Deviation 7.68	—
Period 2: Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF and QTcB Interval QTcF interval, Day 15: 2 hours, n=18	-3.0 Milliseconds Standard Deviation 6.15	—
Period 2: Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF and QTcB Interval QTcF interval, Day 15: 4 hours, n=18	2.4 Milliseconds Standard Deviation 9.71	—
Period 2: Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF and QTcB Interval QTcF interval, Day 15: 6 hours, n=18	8.1 Milliseconds Standard Deviation 9.07	—
Period 2: Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF and QTcB Interval QTcF interval, Day 21, n=18	-0.3 Milliseconds Standard Deviation 6.85	—
Period 2: Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF and QTcB Interval QTcF interval, Day 24, n=17	1.4 Milliseconds Standard Deviation 5.63	—
Period 2: Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF and QTcB Interval QTcB interval, Day 11: 2 hours, n=21	-8.5 Milliseconds Standard Deviation 13.11	—
Period 2: Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF and QTcB Interval QTcB interval, Day 11: 4 hours, n=21	1.0 Milliseconds Standard Deviation 11.57	—
Period 2: Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF and QTcB Interval QTcB interval, Day 11: 6 hours, n=21	8.2 Milliseconds Standard Deviation 11.84	—
Period 2: Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF and QTcB Interval QTcB interval, Day 15: 2 hours, n=18	1.1 Milliseconds Standard Deviation 11.25	—
Period 2: Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF and QTcB Interval QTcB interval, Day 15: 4 hours, n=18	4.4 Milliseconds Standard Deviation 15.09	—
Period 2: Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF and QTcB Interval QTcB interval, Day 15: 6 hours, n=18	11.6 Milliseconds Standard Deviation 12.41	—
Period 2: Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF and QTcB Interval QTcB interval, Day 21, n=18	3.6 Milliseconds Standard Deviation 9.20	—
Period 2: Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF and QTcB Interval QTcB interval, Day 24, n=17	2.5 Milliseconds Standard Deviation 7.67	—

SECONDARY outcome

Timeframe: Baseline (Day 1, Pre-dose) and at Day 10

Population: Safety Population.

SBP and DBP were assessed in the semi-recumbent position with a completely automated device at indicated time-points. Baseline is defined as the average of the triplicate pre-dose assessments. Change from Baseline was defined as post-dose visit value minus Baseline value.

Outcome measures

Outcome measures
Measure	Portia (0.3 mg EE/ 0.15 mg LNG) n=23 Participants Participants in period 1 received Portia (0.3 mg of EE and 0.15 mg LNG) QD on Day 1 through Day 10.	Portia (0.3 mg EE/ 0.15 mg LNG)+GSK3640254 Participants in treatment period 2 were co-administered with GSK3640254 200 mg QD along with Portia from Day 11 through Day 21.
Period 1: Change From Baseline in Vital Signs: Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) SBP	-4.3 Millimeters of mercury Standard Deviation 9.45	—
Period 1: Change From Baseline in Vital Signs: Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) DBP	-2.8 Millimeters of mercury Standard Deviation 7.84	—

SECONDARY outcome

Timeframe: Baseline (Day 11, Pre-dose) and at Days 15, 21 and 24

Population: Safety Population. Only those participants with data available at specified time points were analyzed (represented by n=X in the category titles).

SBP and DBP were assessed in the semi-recumbent position with a completely automated device at indicated time-points. Baseline is defined as as the average of the triplicate pre-dose assessments. Change from Baseline was defined as post-dose visit value minus Baseline value.

Outcome measures

Outcome measures
Measure	Portia (0.3 mg EE/ 0.15 mg LNG) n=21 Participants Participants in period 1 received Portia (0.3 mg of EE and 0.15 mg LNG) QD on Day 1 through Day 10.	Portia (0.3 mg EE/ 0.15 mg LNG)+GSK3640254 Participants in treatment period 2 were co-administered with GSK3640254 200 mg QD along with Portia from Day 11 through Day 21.
Period 2: Change From Baseline in Vital Signs: SBP and DBP SBP, Day 15, n=19	4.4 Millimeters of mercury Standard Deviation 6.51	—
Period 2: Change From Baseline in Vital Signs: SBP and DBP SBP, Day 21, n=18	1.6 Millimeters of mercury Standard Deviation 4.89	—
Period 2: Change From Baseline in Vital Signs: SBP and DBP SBP, Day 24, n=17	5.9 Millimeters of mercury Standard Deviation 6.95	—
Period 2: Change From Baseline in Vital Signs: SBP and DBP DBP, Day 15, n=19	3.0 Millimeters of mercury Standard Deviation 5.08	—
Period 2: Change From Baseline in Vital Signs: SBP and DBP DBP, Day 21, n=18	3.5 Millimeters of mercury Standard Deviation 3.38	—
Period 2: Change From Baseline in Vital Signs: SBP and DBP DBP, Day 24, n=17	6.1 Millimeters of mercury Standard Deviation 5.27	—

SECONDARY outcome

Timeframe: Baseline (Day 1, Pre-dose) and at Day 10

Population: Safety Population.

Pulse rate was assessed in the semi-recumbent position with a completely automated device at indicated time-points. Baseline is defined as the average of the triplicate predose assessments. Change from Baseline was defined as post-dose visit value minus Baseline value.

Outcome measures

Outcome measures
Measure	Portia (0.3 mg EE/ 0.15 mg LNG) n=23 Participants Participants in period 1 received Portia (0.3 mg of EE and 0.15 mg LNG) QD on Day 1 through Day 10.	Portia (0.3 mg EE/ 0.15 mg LNG)+GSK3640254 Participants in treatment period 2 were co-administered with GSK3640254 200 mg QD along with Portia from Day 11 through Day 21.
Period 1: Change From Baseline in Pulse Rate	-0.2 Beats per minute Standard Deviation 5.16	—

SECONDARY outcome

Timeframe: Baseline (Day 11, Pre-dose) and at Days 15, 21 and 24

Population: Safety Population. Only those participants with data available at specified time points were analyzed (represented by n=X in the category titles).

Pulse rate was assessed in the semi-recumbent position with a completely automated device at indicated time-points. Baseline is defined as the average of the triplicate predose assessments. Change from Baseline was defined as post-dose visit value minus Baseline value.

Outcome measures

Outcome measures
Measure	Portia (0.3 mg EE/ 0.15 mg LNG) n=21 Participants Participants in period 1 received Portia (0.3 mg of EE and 0.15 mg LNG) QD on Day 1 through Day 10.	Portia (0.3 mg EE/ 0.15 mg LNG)+GSK3640254 Participants in treatment period 2 were co-administered with GSK3640254 200 mg QD along with Portia from Day 11 through Day 21.
Period 2: Change From Baseline in Pulse Rate Day 15, n=19	5.8 Beats per minute Standard Deviation 5.06	—
Period 2: Change From Baseline in Pulse Rate Day 21, n=18	1.8 Beats per minute Standard Deviation 5.71	—
Period 2: Change From Baseline in Pulse Rate Day 24, n=17	0.9 Beats per minute Standard Deviation 5.48	—

SECONDARY outcome

Timeframe: Baseline (Day 1, Pre-dose) and at Day 10

Population: Safety Population.

Respiratory rate was assessed at indicated time-points. Baseline is defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, within each treatment. Change from Baseline was defined as post-dose visit value minus Baseline value.

Outcome measures

Outcome measures
Measure	Portia (0.3 mg EE/ 0.15 mg LNG) n=23 Participants Participants in period 1 received Portia (0.3 mg of EE and 0.15 mg LNG) QD on Day 1 through Day 10.	Portia (0.3 mg EE/ 0.15 mg LNG)+GSK3640254 Participants in treatment period 2 were co-administered with GSK3640254 200 mg QD along with Portia from Day 11 through Day 21.
Period 1: Change From Baseline in Respiratory Rate	2.3 Breaths per minute Standard Deviation 2.58	—

SECONDARY outcome

Timeframe: Baseline (Day 11, Pre-dose) and at Days 15, 21 and 24

Population: Safety Population. Only those participants with data available at specified time points were analyzed (represented by n=X in the category titles).

Respiratory rate was assessed at indicated time-points. Baseline is defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, within each treatment. Change from Baseline was defined as post-dose visit value minus Baseline value.

Outcome measures

Outcome measures
Measure	Portia (0.3 mg EE/ 0.15 mg LNG) n=21 Participants Participants in period 1 received Portia (0.3 mg of EE and 0.15 mg LNG) QD on Day 1 through Day 10.	Portia (0.3 mg EE/ 0.15 mg LNG)+GSK3640254 Participants in treatment period 2 were co-administered with GSK3640254 200 mg QD along with Portia from Day 11 through Day 21.
Period 2: Change From Baseline in Respiratory Rate Day 15, n=19	1.7 Breaths per minute Standard Deviation 3.07	—
Period 2: Change From Baseline in Respiratory Rate Day 21, n=18	0.6 Breaths per minute Standard Deviation 2.15	—
Period 2: Change From Baseline in Respiratory Rate Day 24, n=17	0.9 Breaths per minute Standard Deviation 3.61	—

SECONDARY outcome

Timeframe: Baseline (Day 1, Pre-dose) and at Day 10

Population: Safety Population.

Temperature was assessed at indicated time-points. Baseline is defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, within each treatment. Change from Baseline was defined as post-dose visit value minus Baseline value.

Outcome measures

Outcome measures
Measure	Portia (0.3 mg EE/ 0.15 mg LNG) n=23 Participants Participants in period 1 received Portia (0.3 mg of EE and 0.15 mg LNG) QD on Day 1 through Day 10.	Portia (0.3 mg EE/ 0.15 mg LNG)+GSK3640254 Participants in treatment period 2 were co-administered with GSK3640254 200 mg QD along with Portia from Day 11 through Day 21.
Period 1: Change From Baseline in Temperature	0.11 Degree Celsius Standard Deviation 0.452	—

SECONDARY outcome

Timeframe: Baseline (Day 11, Pre-dose) and at Days 15, 21 and 24

Population: Safety Population. Only those participants with data available at specified time points were analyzed (represented by n=X in the category titles).

Temperature was assessed at indicated time-points. Baseline is defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, within each treatment. Change from Baseline was defined as post-dose visit value minus Baseline value.

Outcome measures

Outcome measures
Measure	Portia (0.3 mg EE/ 0.15 mg LNG) n=21 Participants Participants in period 1 received Portia (0.3 mg of EE and 0.15 mg LNG) QD on Day 1 through Day 10.	Portia (0.3 mg EE/ 0.15 mg LNG)+GSK3640254 Participants in treatment period 2 were co-administered with GSK3640254 200 mg QD along with Portia from Day 11 through Day 21.
Period 2: Change From Baseline in Temperature Day 15, n=19	0.15 Degree Celsius Standard Deviation 0.434	—
Period 2: Change From Baseline in Temperature Day 21, n=18	0.02 Degree Celsius Standard Deviation 0.537	—
Period 2: Change From Baseline in Temperature Day 24, n=17	0.25 Degree Celsius Standard Deviation 0.505	—

SECONDARY outcome

Timeframe: Baseline (Day 1, Pre-dose) and at Day 10

Population: Safety Population.

Blood samples were collected at indicated time points for the analysis of clinical chemistry parameters including Glucose, cholesterol, triglycerides, anion gap, calcium, carbon dioxide, chloride, phosphate, potassium, sodium and BUN. Baseline is defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, within each treatment.

Outcome measures

Outcome measures
Measure	Portia (0.3 mg EE/ 0.15 mg LNG) n=23 Participants Participants in period 1 received Portia (0.3 mg of EE and 0.15 mg LNG) QD on Day 1 through Day 10.	Portia (0.3 mg EE/ 0.15 mg LNG)+GSK3640254 Participants in treatment period 2 were co-administered with GSK3640254 200 mg QD along with Portia from Day 11 through Day 21.
Period 1: Absolute Values of Clinical Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium and BUN Glucose, Baseline	5.104 Millimoles per liter Standard Deviation 0.5019	—
Period 1: Absolute Values of Clinical Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium and BUN Glucose, Day 10	4.887 Millimoles per liter Standard Deviation 0.4616	—
Period 1: Absolute Values of Clinical Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium and BUN Cholesterol, Baseline	4.291 Millimoles per liter Standard Deviation 0.9991	—
Period 1: Absolute Values of Clinical Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium and BUN Cholesterol, Day 10	4.138 Millimoles per liter Standard Deviation 0.8322	—
Period 1: Absolute Values of Clinical Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium and BUN Triglycerides, Baseline	1.084 Millimoles per liter Standard Deviation 0.5437	—
Period 1: Absolute Values of Clinical Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium and BUN Triglycerides, Day 10	1.035 Millimoles per liter Standard Deviation 0.3940	—
Period 1: Absolute Values of Clinical Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium and BUN Anion gap, Baseline	9.9 Millimoles per liter Standard Deviation 1.10	—
Period 1: Absolute Values of Clinical Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium and BUN Anion gap, Day 10	11.2 Millimoles per liter Standard Deviation 1.44	—
Period 1: Absolute Values of Clinical Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium and BUN Calcium, Baseline	2.310 Millimoles per liter Standard Deviation 0.0652	—
Period 1: Absolute Values of Clinical Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium and BUN Calcium, Day 10	2.349 Millimoles per liter Standard Deviation 0.0593	—
Period 1: Absolute Values of Clinical Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium and BUN Carbon dioxide, Baseline	28.0 Millimoles per liter Standard Deviation 1.17	—
Period 1: Absolute Values of Clinical Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium and BUN Carbon dioxide, Day 10	26.2 Millimoles per liter Standard Deviation 1.44	—
Period 1: Absolute Values of Clinical Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium and BUN Chloride, Baseline	103.4 Millimoles per liter Standard Deviation 1.41	—
Period 1: Absolute Values of Clinical Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium and BUN Chloride, Day 10	103.6 Millimoles per liter Standard Deviation 1.83	—
Period 1: Absolute Values of Clinical Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium and BUN Phosphate, Baseline	1.165 Millimoles per liter Standard Deviation 0.1000	—
Period 1: Absolute Values of Clinical Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium and BUN Phosphate, Day 10	1.135 Millimoles per liter Standard Deviation 0.0881	—
Period 1: Absolute Values of Clinical Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium and BUN Potassium, Baseline	4.23 Millimoles per liter Standard Deviation 0.288	—
Period 1: Absolute Values of Clinical Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium and BUN Potassium, Day 10	4.20 Millimoles per liter Standard Deviation 0.265	—
Period 1: Absolute Values of Clinical Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium and BUN Sodium, Baseline	137.1 Millimoles per liter Standard Deviation 1.24	—
Period 1: Absolute Values of Clinical Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium and BUN Sodium, Day 10	136.7 Millimoles per liter Standard Deviation 1.57	—
Period 1: Absolute Values of Clinical Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium and BUN BUN, Baseline	3.659 Millimoles per liter Standard Deviation 0.7512	—
Period 1: Absolute Values of Clinical Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium and BUN BUN, Day 10	3.478 Millimoles per liter Standard Deviation 0.6738	—

SECONDARY outcome

Timeframe: Baseline (Day 10) and at Days 21 and 24

Population: Safety Population. Only those participants with data available at specified time points were analyzed (represented by n=X in the category titles).

Blood samples were collected at indicated time points for the analysis of clinical chemistry parameters including Glucose, cholesterol, triglycerides, anion gap, calcium, carbon dioxide, chloride, phosphate, potassium, sodium and BUN. Baseline is defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, within each treatment.

Outcome measures

Outcome measures
Measure	Portia (0.3 mg EE/ 0.15 mg LNG) n=21 Participants Participants in period 1 received Portia (0.3 mg of EE and 0.15 mg LNG) QD on Day 1 through Day 10.	Portia (0.3 mg EE/ 0.15 mg LNG)+GSK3640254 Participants in treatment period 2 were co-administered with GSK3640254 200 mg QD along with Portia from Day 11 through Day 21.
Period 2: Absolute Values of Clinical Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium and BUN Glucose, Baseline, n=21	4.921 Millimoles per liter Standard Deviation 0.4503	—
Period 2: Absolute Values of Clinical Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium and BUN Glucose, Day 21, n=17	4.769 Millimoles per liter Standard Deviation 0.3922	—
Period 2: Absolute Values of Clinical Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium and BUN Glucose, Day 24, n=17	4.994 Millimoles per liter Standard Deviation 0.3746	—
Period 2: Absolute Values of Clinical Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium and BUN Cholesterol, Baseline, n=21	4.104 Millimoles per liter Standard Deviation 0.8622	—
Period 2: Absolute Values of Clinical Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium and BUN Cholesterol, Day 21, n=17	3.857 Millimoles per liter Standard Deviation 0.8765	—
Period 2: Absolute Values of Clinical Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium and BUN Cholesterol, Day 24, n=17	4.093 Millimoles per liter Standard Deviation 1.0474	—
Period 2: Absolute Values of Clinical Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium and BUN Triglycerides, Baseline, n=21	1.032 Millimoles per liter Standard Deviation 0.4092	—
Period 2: Absolute Values of Clinical Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium and BUN Triglycerides, Day 21, n=17	1.080 Millimoles per liter Standard Deviation 0.4505	—
Period 2: Absolute Values of Clinical Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium and BUN Triglycerides, Day 24, n=17	1.022 Millimoles per liter Standard Deviation 0.5161	—
Period 2: Absolute Values of Clinical Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium and BUN Anion gap, Baseline, n=21	11.2 Millimoles per liter Standard Deviation 1.48	—
Period 2: Absolute Values of Clinical Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium and BUN Anion gap, Day 21, n=17	9.6 Millimoles per liter Standard Deviation 1.46	—
Period 2: Absolute Values of Clinical Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium and BUN Anion gap, Day 24, n=17	10.5 Millimoles per liter Standard Deviation 1.42	—
Period 2: Absolute Values of Clinical Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium and BUN Calcium, Baseline, n=21	2.349 Millimoles per liter Standard Deviation 0.0602	—
Period 2: Absolute Values of Clinical Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium and BUN Calcium, Day 21, n=17	2.314 Millimoles per liter Standard Deviation 0.0706	—
Period 2: Absolute Values of Clinical Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium and BUN Calcium, Day 24, n=17	2.348 Millimoles per liter Standard Deviation 0.0592	—
Period 2: Absolute Values of Clinical Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium and BUN Carbon dioxide, Baseline, n=21	26.0 Millimoles per liter Standard Deviation 1.43	—
Period 2: Absolute Values of Clinical Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium and BUN Carbon dioxide, Day 21, n=17	26.7 Millimoles per liter Standard Deviation 1.57	—
Period 2: Absolute Values of Clinical Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium and BUN Carbon dioxide, Day 24, n=17	27.6 Millimoles per liter Standard Deviation 1.33	—
Period 2: Absolute Values of Clinical Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium and BUN Chloride, Baseline, n=21	103.7 Millimoles per liter Standard Deviation 1.74	—
Period 2: Absolute Values of Clinical Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium and BUN Chloride, Day 21, n=17	103.0 Millimoles per liter Standard Deviation 2.18	—
Period 2: Absolute Values of Clinical Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium and BUN Chloride, Day 24, n=17	104.1 Millimoles per liter Standard Deviation 2.01	—
Period 2: Absolute Values of Clinical Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium and BUN Phosphate, Baseline, n=21	1.139 Millimoles per liter Standard Deviation 0.0819	—
Period 2: Absolute Values of Clinical Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium and BUN Phosphate, Day 21, n=17	1.055 Millimoles per liter Standard Deviation 0.0908	—
Period 2: Absolute Values of Clinical Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium and BUN Phosphate, Day 24, n=17	1.065 Millimoles per liter Standard Deviation 0.0818	—
Period 2: Absolute Values of Clinical Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium and BUN Potassium, Baseline, n=21	4.18 Millimoles per liter Standard Deviation 0.211	—
Period 2: Absolute Values of Clinical Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium and BUN Potassium, Day 21, n=17	4.12 Millimoles per liter Standard Deviation 0.198	—
Period 2: Absolute Values of Clinical Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium and BUN Potassium, Day 24, n=17	4.16 Millimoles per liter Standard Deviation 0.197	—
Period 2: Absolute Values of Clinical Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium and BUN Sodium, Baseline, n=21	136.9 Millimoles per liter Standard Deviation 1.39	—
Period 2: Absolute Values of Clinical Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium and BUN Sodium, Day 21, n=17	135.4 Millimoles per liter Standard Deviation 1.46	—
Period 2: Absolute Values of Clinical Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium and BUN Sodium, Day 24, n=17	138.1 Millimoles per liter Standard Deviation 1.56	—
Period 2: Absolute Values of Clinical Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium and BUN BUN, Baseline, n=21	3.458 Millimoles per liter Standard Deviation 0.6189	—
Period 2: Absolute Values of Clinical Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium and BUN BUN, Day 21, n=17	2.756 Millimoles per liter Standard Deviation 0.4593	—
Period 2: Absolute Values of Clinical Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium and BUN BUN, Day 24, n=17	2.853 Millimoles per liter Standard Deviation 0.5406	—

SECONDARY outcome

Timeframe: Baseline (Day 1, Pre-dose) and at Day 10

Population: Safety Population.

Blood samples were collected at indicated time points for the analysis of clinical chemistry parameters including plasma albumin, globulin and protein. Baseline is defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, within each treatment.

Outcome measures

Outcome measures
Measure	Portia (0.3 mg EE/ 0.15 mg LNG) n=23 Participants Participants in period 1 received Portia (0.3 mg of EE and 0.15 mg LNG) QD on Day 1 through Day 10.	Portia (0.3 mg EE/ 0.15 mg LNG)+GSK3640254 Participants in treatment period 2 were co-administered with GSK3640254 200 mg QD along with Portia from Day 11 through Day 21.
Period 1: Absolute Values of Clinical Chemistry Parameters: Plasma Albumin, Globulin and Protein Albumin, Baseline	42.0 Grams per liter Standard Deviation 2.29	—
Period 1: Absolute Values of Clinical Chemistry Parameters: Plasma Albumin, Globulin and Protein Albumin, Day 10	42.0 Grams per liter Standard Deviation 2.16	—
Period 1: Absolute Values of Clinical Chemistry Parameters: Plasma Albumin, Globulin and Protein Globulin, Baseline	28.8 Grams per liter Standard Deviation 2.57	—
Period 1: Absolute Values of Clinical Chemistry Parameters: Plasma Albumin, Globulin and Protein Globulin, Day 10	29.8 Grams per liter Standard Deviation 2.93	—
Period 1: Absolute Values of Clinical Chemistry Parameters: Plasma Albumin, Globulin and Protein Protein, Baseline	70.9 Grams per liter Standard Deviation 4.06	—
Period 1: Absolute Values of Clinical Chemistry Parameters: Plasma Albumin, Globulin and Protein Protein, Day 10	71.8 Grams per liter Standard Deviation 4.25	—

SECONDARY outcome

Timeframe: Baseline (Day 10) and at Days 21 and 24

Population: Safety Population. Only those participants with data available at specified time points were analyzed (represented by n=X in the category titles).

Blood samples were collected at indicated time points for the analysis of clinical chemistry parameters including plasma albumin, globulin and protein. Baseline is defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, within each treatment.

Outcome measures

Outcome measures
Measure	Portia (0.3 mg EE/ 0.15 mg LNG) n=21 Participants Participants in period 1 received Portia (0.3 mg of EE and 0.15 mg LNG) QD on Day 1 through Day 10.	Portia (0.3 mg EE/ 0.15 mg LNG)+GSK3640254 Participants in treatment period 2 were co-administered with GSK3640254 200 mg QD along with Portia from Day 11 through Day 21.
Period 2: Absolute Values of Clinical Chemistry Parameters: Plasma Albumin, Globulin and Protein Albumin, Baseline, n=21	41.9 Grams per liter Standard Deviation 2.21	—
Period 2: Absolute Values of Clinical Chemistry Parameters: Plasma Albumin, Globulin and Protein Albumin, Day 21, n=17	41.4 Grams per liter Standard Deviation 1.62	—
Period 2: Absolute Values of Clinical Chemistry Parameters: Plasma Albumin, Globulin and Protein Albumin, Day 24, n=17	42.0 Grams per liter Standard Deviation 2.12	—
Period 2: Absolute Values of Clinical Chemistry Parameters: Plasma Albumin, Globulin and Protein Globulin, Baseline, n=21	29.7 Grams per liter Standard Deviation 2.99	—
Period 2: Absolute Values of Clinical Chemistry Parameters: Plasma Albumin, Globulin and Protein Globulin, Day 21, n=17	29.2 Grams per liter Standard Deviation 2.70	—
Period 2: Absolute Values of Clinical Chemistry Parameters: Plasma Albumin, Globulin and Protein Globulin, Day 24, n=17	30.4 Grams per liter Standard Deviation 2.50	—
Period 2: Absolute Values of Clinical Chemistry Parameters: Plasma Albumin, Globulin and Protein Protein, Baseline, n=21	71.6 Grams per liter Standard Deviation 4.40	—
Period 2: Absolute Values of Clinical Chemistry Parameters: Plasma Albumin, Globulin and Protein Protein, Day 21, n=17	70.5 Grams per liter Standard Deviation 3.68	—
Period 2: Absolute Values of Clinical Chemistry Parameters: Plasma Albumin, Globulin and Protein Protein, Day 24, n=17	72.4 Grams per liter Standard Deviation 3.97	—

SECONDARY outcome

Timeframe: Baseline (Day 1, Pre-dose) and at Day 10

Population: Safety Population.

Blood samples were collected at indicated time points for the analysis of clinical chemistry parameters including plasma amylase and lipase. Baseline is defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, within each treatment.

Outcome measures

Outcome measures
Measure	Portia (0.3 mg EE/ 0.15 mg LNG) n=23 Participants Participants in period 1 received Portia (0.3 mg of EE and 0.15 mg LNG) QD on Day 1 through Day 10.	Portia (0.3 mg EE/ 0.15 mg LNG)+GSK3640254 Participants in treatment period 2 were co-administered with GSK3640254 200 mg QD along with Portia from Day 11 through Day 21.
Period 1: Absolute Values of Clinical Chemistry Parameters: Plasma Amylase and Lipase Amylase, Baseline	49.4 Units per liter Standard Deviation 18.77	—
Period 1: Absolute Values of Clinical Chemistry Parameters: Plasma Amylase and Lipase Amylase, Day 10	48.7 Units per liter Standard Deviation 16.34	—
Period 1: Absolute Values of Clinical Chemistry Parameters: Plasma Amylase and Lipase Lipase, Baseline	18.8 Units per liter Standard Deviation 9.25	—
Period 1: Absolute Values of Clinical Chemistry Parameters: Plasma Amylase and Lipase Lipase, Day 10	20.9 Units per liter Standard Deviation 8.47	—

SECONDARY outcome

Timeframe: Baseline (Day 10) and at Days 21 and 24

Population: Safety Population. Only those participants with data available at specified time points were analyzed (represented by n=X in the category titles).

Blood samples were collected at indicated time points for the analysis of clinical chemistry parameters including plasma amylase and lipase. Baseline is defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, within each treatment.

Outcome measures

Outcome measures
Measure	Portia (0.3 mg EE/ 0.15 mg LNG) n=21 Participants Participants in period 1 received Portia (0.3 mg of EE and 0.15 mg LNG) QD on Day 1 through Day 10.	Portia (0.3 mg EE/ 0.15 mg LNG)+GSK3640254 Participants in treatment period 2 were co-administered with GSK3640254 200 mg QD along with Portia from Day 11 through Day 21.
Period 2: Absolute Values of Clinical Chemistry Parameters: Plasma Amylase and Lipase Amylase, Baseline, n=21	47.8 Units per liter Standard Deviation 16.79	—
Period 2: Absolute Values of Clinical Chemistry Parameters: Plasma Amylase and Lipase Amylase, Day 21, n=17	47.1 Units per liter Standard Deviation 17.93	—
Period 2: Absolute Values of Clinical Chemistry Parameters: Plasma Amylase and Lipase Amylase, Day 24, n=17	49.2 Units per liter Standard Deviation 18.38	—
Period 2: Absolute Values of Clinical Chemistry Parameters: Plasma Amylase and Lipase Lipase, Baseline, n=21	20.7 Units per liter Standard Deviation 8.83	—
Period 2: Absolute Values of Clinical Chemistry Parameters: Plasma Amylase and Lipase Lipase, Day 21, n=17	20.5 Units per liter Standard Deviation 7.40	—
Period 2: Absolute Values of Clinical Chemistry Parameters: Plasma Amylase and Lipase Lipase, Day 24, n=17	20.4 Units per liter Standard Deviation 8.16	—

SECONDARY outcome

Timeframe: Baseline (Day 1, Pre-dose) and at Day 10

Population: Safety Population.

Blood samples were collected at indicated time points for the analysis of clinical chemistry parameters including creatine kinase, lactate dehydrogenase, ALT, ALP, AST and GGT. Baseline is defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, within each treatment.

Outcome measures

Outcome measures
Measure	Portia (0.3 mg EE/ 0.15 mg LNG) n=23 Participants Participants in period 1 received Portia (0.3 mg of EE and 0.15 mg LNG) QD on Day 1 through Day 10.	Portia (0.3 mg EE/ 0.15 mg LNG)+GSK3640254 Participants in treatment period 2 were co-administered with GSK3640254 200 mg QD along with Portia from Day 11 through Day 21.
Period 1: Absolute Values of Clinical Chemistry Parameters: Creatine Kinase, Lactate Dehydrogenase, ALT, ALP, AST and GGT Creatine kinase, Baseline	74.1 International units per liter Standard Deviation 25.37	—
Period 1: Absolute Values of Clinical Chemistry Parameters: Creatine Kinase, Lactate Dehydrogenase, ALT, ALP, AST and GGT Creatine kinase, Day 10	70.5 International units per liter Standard Deviation 22.43	—
Period 1: Absolute Values of Clinical Chemistry Parameters: Creatine Kinase, Lactate Dehydrogenase, ALT, ALP, AST and GGT Lactate dehydrogenase, Baseline	122.7 International units per liter Standard Deviation 21.78	—
Period 1: Absolute Values of Clinical Chemistry Parameters: Creatine Kinase, Lactate Dehydrogenase, ALT, ALP, AST and GGT Lactate dehydrogenase, Day 10	122.7 International units per liter Standard Deviation 21.19	—
Period 1: Absolute Values of Clinical Chemistry Parameters: Creatine Kinase, Lactate Dehydrogenase, ALT, ALP, AST and GGT ALT, Baseline	12.4 International units per liter Standard Deviation 6.45	—
Period 1: Absolute Values of Clinical Chemistry Parameters: Creatine Kinase, Lactate Dehydrogenase, ALT, ALP, AST and GGT ALT, Day 10	23.9 International units per liter Standard Deviation 24.34	—
Period 1: Absolute Values of Clinical Chemistry Parameters: Creatine Kinase, Lactate Dehydrogenase, ALT, ALP, AST and GGT ALP, Baseline	49.6 International units per liter Standard Deviation 12.00	—
Period 1: Absolute Values of Clinical Chemistry Parameters: Creatine Kinase, Lactate Dehydrogenase, ALT, ALP, AST and GGT ALP, Day 10	45.7 International units per liter Standard Deviation 11.64	—
Period 1: Absolute Values of Clinical Chemistry Parameters: Creatine Kinase, Lactate Dehydrogenase, ALT, ALP, AST and GGT AST, Baseline	14.2 International units per liter Standard Deviation 2.79	—
Period 1: Absolute Values of Clinical Chemistry Parameters: Creatine Kinase, Lactate Dehydrogenase, ALT, ALP, AST and GGT AST, Day 10	17.7 International units per liter Standard Deviation 9.26	—
Period 1: Absolute Values of Clinical Chemistry Parameters: Creatine Kinase, Lactate Dehydrogenase, ALT, ALP, AST and GGT GGT, Baseline	14.9 International units per liter Standard Deviation 5.62	—
Period 1: Absolute Values of Clinical Chemistry Parameters: Creatine Kinase, Lactate Dehydrogenase, ALT, ALP, AST and GGT GGT, Day 10	16.7 International units per liter Standard Deviation 11.48	—

SECONDARY outcome

Timeframe: Baseline (Day 10) and at Days 21 and 24

Population: Safety Population. Only those participants with data available at specified time points were analyzed (represented by n=X in the category titles).

Blood samples were collected at indicated time points for the analysis of clinical chemistry parameters including Plasma creatine kinase, lactate dehydrogenase, ALT, ALP, AST and GGT. Baseline is defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, within each treatment.

Outcome measures

Outcome measures
Measure	Portia (0.3 mg EE/ 0.15 mg LNG) n=21 Participants Participants in period 1 received Portia (0.3 mg of EE and 0.15 mg LNG) QD on Day 1 through Day 10.	Portia (0.3 mg EE/ 0.15 mg LNG)+GSK3640254 Participants in treatment period 2 were co-administered with GSK3640254 200 mg QD along with Portia from Day 11 through Day 21.
Period 2: Absolute Values of Clinical Chemistry Parameters: Plasma Creatine Kinase, Lactate Dehydrogenase, ALT, ALP, AST and GGT Creatine kinase, Baseline, n=21	70.3 International units per liter Standard Deviation 23.37	—
Period 2: Absolute Values of Clinical Chemistry Parameters: Plasma Creatine Kinase, Lactate Dehydrogenase, ALT, ALP, AST and GGT Creatine kinase, Day 21, n=17	69.4 International units per liter Standard Deviation 23.62	—
Period 2: Absolute Values of Clinical Chemistry Parameters: Plasma Creatine Kinase, Lactate Dehydrogenase, ALT, ALP, AST and GGT Creatine kinase, Day 24, n=17	69.3 International units per liter Standard Deviation 22.46	—
Period 2: Absolute Values of Clinical Chemistry Parameters: Plasma Creatine Kinase, Lactate Dehydrogenase, ALT, ALP, AST and GGT Lactate dehydrogenase, Baseline, n=21	123.3 International units per liter Standard Deviation 21.96	—
Period 2: Absolute Values of Clinical Chemistry Parameters: Plasma Creatine Kinase, Lactate Dehydrogenase, ALT, ALP, AST and GGT Lactate dehydrogenase, Day 21, n=17	125.9 International units per liter Standard Deviation 24.85	—
Period 2: Absolute Values of Clinical Chemistry Parameters: Plasma Creatine Kinase, Lactate Dehydrogenase, ALT, ALP, AST and GGT Lactate dehydrogenase, Day 24, n=17	130.1 International units per liter Standard Deviation 27.63	—
Period 2: Absolute Values of Clinical Chemistry Parameters: Plasma Creatine Kinase, Lactate Dehydrogenase, ALT, ALP, AST and GGT ALT, Baseline, n=21	25.7 International units per liter Standard Deviation 27.34	—
Period 2: Absolute Values of Clinical Chemistry Parameters: Plasma Creatine Kinase, Lactate Dehydrogenase, ALT, ALP, AST and GGT ALT, Day 21, n=17	42.2 International units per liter Standard Deviation 32.02	—
Period 2: Absolute Values of Clinical Chemistry Parameters: Plasma Creatine Kinase, Lactate Dehydrogenase, ALT, ALP, AST and GGT ALT, Day 24, n=17	51.1 International units per liter Standard Deviation 45.07	—
Period 2: Absolute Values of Clinical Chemistry Parameters: Plasma Creatine Kinase, Lactate Dehydrogenase, ALT, ALP, AST and GGT ALP, Baseline, n=21	44.9 International units per liter Standard Deviation 10.91	—
Period 2: Absolute Values of Clinical Chemistry Parameters: Plasma Creatine Kinase, Lactate Dehydrogenase, ALT, ALP, AST and GGT ALP, Day 21, n=17	43.5 International units per liter Standard Deviation 10.46	—
Period 2: Absolute Values of Clinical Chemistry Parameters: Plasma Creatine Kinase, Lactate Dehydrogenase, ALT, ALP, AST and GGT ALP, Day 24, n=17	42.6 International units per liter Standard Deviation 10.10	—
Period 2: Absolute Values of Clinical Chemistry Parameters: Plasma Creatine Kinase, Lactate Dehydrogenase, ALT, ALP, AST and GGT AST, Baseline, n=21	17.7 International units per liter Standard Deviation 9.05	—
Period 2: Absolute Values of Clinical Chemistry Parameters: Plasma Creatine Kinase, Lactate Dehydrogenase, ALT, ALP, AST and GGT AST, Day 21, n=17	25.4 International units per liter Standard Deviation 14.55	—
Period 2: Absolute Values of Clinical Chemistry Parameters: Plasma Creatine Kinase, Lactate Dehydrogenase, ALT, ALP, AST and GGT AST, Day 24, n=17	27.9 International units per liter Standard Deviation 20.07	—
Period 2: Absolute Values of Clinical Chemistry Parameters: Plasma Creatine Kinase, Lactate Dehydrogenase, ALT, ALP, AST and GGT GGT, Baseline, n=21	16.4 International units per liter Standard Deviation 11.60	—
Period 2: Absolute Values of Clinical Chemistry Parameters: Plasma Creatine Kinase, Lactate Dehydrogenase, ALT, ALP, AST and GGT GGT, Day 21, n=17	13.0 International units per liter Standard Deviation 4.53	—
Period 2: Absolute Values of Clinical Chemistry Parameters: Plasma Creatine Kinase, Lactate Dehydrogenase, ALT, ALP, AST and GGT GGT, Day 24, n=17	13.1 International units per liter Standard Deviation 4.45	—

SECONDARY outcome

Timeframe: Baseline (Day 1, Pre-dose) and at Day 10

Population: Safety Population.

Blood samples were collected at indicated time points for the analysis of clinical chemistry parameters including Plasma urate, creatinine, total bilirubin and direct bilirubin. Baseline is defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, within each treatment.

Outcome measures

Outcome measures
Measure	Portia (0.3 mg EE/ 0.15 mg LNG) n=23 Participants Participants in period 1 received Portia (0.3 mg of EE and 0.15 mg LNG) QD on Day 1 through Day 10.	Portia (0.3 mg EE/ 0.15 mg LNG)+GSK3640254 Participants in treatment period 2 were co-administered with GSK3640254 200 mg QD along with Portia from Day 11 through Day 21.
Period 1: Absolute Values of Clinical Chemistry Parameters: Urate, Creatinine, Total Bilirubin and Direct Bilirubin Urate, Baseline	260.4 Micromoles per liter Standard Deviation 46.10	—
Period 1: Absolute Values of Clinical Chemistry Parameters: Urate, Creatinine, Total Bilirubin and Direct Bilirubin Urate, Day 10	242.4 Micromoles per liter Standard Deviation 46.30	—
Period 1: Absolute Values of Clinical Chemistry Parameters: Urate, Creatinine, Total Bilirubin and Direct Bilirubin Creatinine, Baseline	67.75 Micromoles per liter Standard Deviation 8.763	—
Period 1: Absolute Values of Clinical Chemistry Parameters: Urate, Creatinine, Total Bilirubin and Direct Bilirubin Creatinine, Day 10	68.68 Micromoles per liter Standard Deviation 9.846	—
Period 1: Absolute Values of Clinical Chemistry Parameters: Urate, Creatinine, Total Bilirubin and Direct Bilirubin Total bilirubin, Baseline	8.35 Micromoles per liter Standard Deviation 3.847	—
Period 1: Absolute Values of Clinical Chemistry Parameters: Urate, Creatinine, Total Bilirubin and Direct Bilirubin Total bilirubin, Day 10	7.79 Micromoles per liter Standard Deviation 3.480	—
Period 1: Absolute Values of Clinical Chemistry Parameters: Urate, Creatinine, Total Bilirubin and Direct Bilirubin Direct bilirubin, Baseline	1.88 Micromoles per liter Standard Deviation 0.871	—
Period 1: Absolute Values of Clinical Chemistry Parameters: Urate, Creatinine, Total Bilirubin and Direct Bilirubin Direct bilirubin, Day 10	1.67 Micromoles per liter Standard Deviation 0.701	—

SECONDARY outcome

Timeframe: Baseline (Day 10) and at Days 21 and 24

Population: Safety Population. Only those participants with data available at specified time points were analyzed (represented by n=X in the category titles).

Blood samples were collected at indicated time points for the analysis of clinical chemistry parameters including Plasma urate, creatinine, total bilirubin and direct bilirubin. Baseline is defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, within each treatment.

Outcome measures

Outcome measures
Measure	Portia (0.3 mg EE/ 0.15 mg LNG) n=21 Participants Participants in period 1 received Portia (0.3 mg of EE and 0.15 mg LNG) QD on Day 1 through Day 10.	Portia (0.3 mg EE/ 0.15 mg LNG)+GSK3640254 Participants in treatment period 2 were co-administered with GSK3640254 200 mg QD along with Portia from Day 11 through Day 21.
Period 2: Absolute Values of Clinical Chemistry Parameters: Plasma Urate, Creatinine, Total Bilirubin and Direct Bilirubin Urate, Baseline, n=21	240.3 Micromoles per liter Standard Deviation 43.74	—
Period 2: Absolute Values of Clinical Chemistry Parameters: Plasma Urate, Creatinine, Total Bilirubin and Direct Bilirubin Urate, Day 21, n=17	194.5 Micromoles per liter Standard Deviation 35.17	—
Period 2: Absolute Values of Clinical Chemistry Parameters: Plasma Urate, Creatinine, Total Bilirubin and Direct Bilirubin Urate, Day 24, n=17	205.1 Micromoles per liter Standard Deviation 39.09	—
Period 2: Absolute Values of Clinical Chemistry Parameters: Plasma Urate, Creatinine, Total Bilirubin and Direct Bilirubin Creatinine, Baseline, n=21	68.62 Micromoles per liter Standard Deviation 10.637	—
Period 2: Absolute Values of Clinical Chemistry Parameters: Plasma Urate, Creatinine, Total Bilirubin and Direct Bilirubin Creatinine, Day 21, n=17	66.92 Micromoles per liter Standard Deviation 6.770	—
Period 2: Absolute Values of Clinical Chemistry Parameters: Plasma Urate, Creatinine, Total Bilirubin and Direct Bilirubin Creatinine, Day 24, n=17	67.70 Micromoles per liter Standard Deviation 7.456	—
Period 2: Absolute Values of Clinical Chemistry Parameters: Plasma Urate, Creatinine, Total Bilirubin and Direct Bilirubin Total bilirubin, Baseline, n=21	7.98 Micromoles per liter Standard Deviation 3.563	—
Period 2: Absolute Values of Clinical Chemistry Parameters: Plasma Urate, Creatinine, Total Bilirubin and Direct Bilirubin Total bilirubin, Day 21, n=17	6.94 Micromoles per liter Standard Deviation 1.600	—
Period 2: Absolute Values of Clinical Chemistry Parameters: Plasma Urate, Creatinine, Total Bilirubin and Direct Bilirubin Total bilirubin, Day 24, n=17	6.99 Micromoles per liter Standard Deviation 2.323	—
Period 2: Absolute Values of Clinical Chemistry Parameters: Plasma Urate, Creatinine, Total Bilirubin and Direct Bilirubin Direct bilirubin, Baseline, n=21	1.72 Micromoles per liter Standard Deviation 0.699	—
Period 2: Absolute Values of Clinical Chemistry Parameters: Plasma Urate, Creatinine, Total Bilirubin and Direct Bilirubin Direct bilirubin, Day 21, n=17	1.56 Micromoles per liter Standard Deviation 0.498	—
Period 2: Absolute Values of Clinical Chemistry Parameters: Plasma Urate, Creatinine, Total Bilirubin and Direct Bilirubin Direct bilirubin, Day 24, n=17	1.64 Micromoles per liter Standard Deviation 0.592	—

SECONDARY outcome

Timeframe: Baseline (Day 1, Pre-dose) and at Day 10

Population: Safety Population.

Blood samples were collected at indicated time points for the analysis of hematology parameters including Basophils, eosinophils, leukocytes, lymphocytes, monocytes, neutrophils and platelets. Baseline is defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, within each treatment.

Outcome measures

Outcome measures
Measure	Portia (0.3 mg EE/ 0.15 mg LNG) n=23 Participants Participants in period 1 received Portia (0.3 mg of EE and 0.15 mg LNG) QD on Day 1 through Day 10.	Portia (0.3 mg EE/ 0.15 mg LNG)+GSK3640254 Participants in treatment period 2 were co-administered with GSK3640254 200 mg QD along with Portia from Day 11 through Day 21.
Period 1: Absolute Values of Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets Basophils, Baseline	0.038 10^9 cells per liter Standard Deviation 0.0239	—
Period 1: Absolute Values of Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets Basophils, Day 10	0.038 10^9 cells per liter Standard Deviation 0.0177	—
Period 1: Absolute Values of Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets Eosinophils, Baseline	0.103 10^9 cells per liter Standard Deviation 0.0555	—
Period 1: Absolute Values of Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets Eosinophils, Day 10	0.111 10^9 cells per liter Standard Deviation 0.0606	—
Period 1: Absolute Values of Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets Leukocytes, Baseline	6.23 10^9 cells per liter Standard Deviation 1.626	—
Period 1: Absolute Values of Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets Leukocytes, Day 10	6.21 10^9 cells per liter Standard Deviation 1.329	—
Period 1: Absolute Values of Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets Lymphocytes, Baseline	1.730 10^9 cells per liter Standard Deviation 0.3832	—
Period 1: Absolute Values of Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets Lymphocytes, Day 10	1.816 10^9 cells per liter Standard Deviation 0.3399	—
Period 1: Absolute Values of Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets Monocytes, Baseline	0.460 10^9 cells per liter Standard Deviation 0.1238	—
Period 1: Absolute Values of Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets Monocytes, Day 10	0.448 10^9 cells per liter Standard Deviation 0.1144	—
Period 1: Absolute Values of Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets Neutrophils, Baseline	3.905 10^9 cells per liter Standard Deviation 1.2865	—
Period 1: Absolute Values of Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets Neutrophils, Day 10	3.802 10^9 cells per liter Standard Deviation 1.1472	—
Period 1: Absolute Values of Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets Platelets, Baseline	284.4 10^9 cells per liter Standard Deviation 36.78	—
Period 1: Absolute Values of Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets Platelets, Day 10	282.8 10^9 cells per liter Standard Deviation 45.94	—

SECONDARY outcome

Timeframe: Baseline (Day 10) and at Days 21 and 24

Population: Safety Population. Only those participants with data available at specified time points were analyzed (represented by n=X in the category titles).

Blood samples were collected at indicated time points for the analysis of hematology parameters including Basophils, eosinophils, leukocytes, lymphocytes, monocytes, neutrophils and platelets. Baseline is defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, within each treatment.

Outcome measures

Outcome measures
Measure	Portia (0.3 mg EE/ 0.15 mg LNG) n=21 Participants Participants in period 1 received Portia (0.3 mg of EE and 0.15 mg LNG) QD on Day 1 through Day 10.	Portia (0.3 mg EE/ 0.15 mg LNG)+GSK3640254 Participants in treatment period 2 were co-administered with GSK3640254 200 mg QD along with Portia from Day 11 through Day 21.
Period 2: Absolute Values of Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets Lymphocytes, Baseline, n=21	1.790 10^9 cells per liter Standard Deviation 0.3089	—
Period 2: Absolute Values of Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets Lymphocytes, Day 21, n=17	1.715 10^9 cells per liter Standard Deviation 0.3349	—
Period 2: Absolute Values of Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets Lymphocytes, Day 24, n=17	1.710 10^9 cells per liter Standard Deviation 0.2207	—
Period 2: Absolute Values of Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets Basophils, Baseline, n=21	0.039 10^9 cells per liter Standard Deviation 0.0184	—
Period 2: Absolute Values of Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets Basophils, Day 21, n=17	0.039 10^9 cells per liter Standard Deviation 0.0183	—
Period 2: Absolute Values of Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets Basophils, Day 24, n=17	0.038 10^9 cells per liter Standard Deviation 0.0142	—
Period 2: Absolute Values of Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets Eosinophils, Baseline, n=21	0.115 10^9 cells per liter Standard Deviation 0.0622	—
Period 2: Absolute Values of Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets Eosinophils, Day 21, n=17	0.118 10^9 cells per liter Standard Deviation 0.0631	—
Period 2: Absolute Values of Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets Eosinophils, Day 24, n=17	0.112 10^9 cells per liter Standard Deviation 0.0645	—
Period 2: Absolute Values of Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets Leukocytes, Baseline, n=21	6.20 10^9 cells per liter Standard Deviation 1.391	—
Period 2: Absolute Values of Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets Leukocytes, Day 21, n=17	5.86 10^9 cells per liter Standard Deviation 1.183	—
Period 2: Absolute Values of Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets Leukocytes, Day 24, n=17	5.41 10^9 cells per liter Standard Deviation 1.080	—
Period 2: Absolute Values of Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets Monocytes, Baseline, n=21	0.446 10^9 cells per liter Standard Deviation 0.1186	—
Period 2: Absolute Values of Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets Monocytes, Day 21, n=17	0.409 10^9 cells per liter Standard Deviation 0.0942	—
Period 2: Absolute Values of Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets Monocytes, Day 24, n=17	0.391 10^9 cells per liter Standard Deviation 0.0924	—
Period 2: Absolute Values of Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets Neutrophils, Baseline, n=21	3.811 10^9 cells per liter Standard Deviation 1.2013	—
Period 2: Absolute Values of Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets Neutrophils, Day 21, n=17	3.587 10^9 cells per liter Standard Deviation 1.0893	—
Period 2: Absolute Values of Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets Neutrophils, Day 24, n=17	3.165 10^9 cells per liter Standard Deviation 0.9633	—
Period 2: Absolute Values of Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets Platelets, Baseline, n=21	282.2 10^9 cells per liter Standard Deviation 46.73	—
Period 2: Absolute Values of Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets Platelets, Day 21, n=17	296.8 10^9 cells per liter Standard Deviation 50.45	—
Period 2: Absolute Values of Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets Platelets, Day 24, n=17	291.4 10^9 cells per liter Standard Deviation 42.75	—

SECONDARY outcome

Timeframe: Baseline (Day 1, Pre-dose) and at Day 10

Population: Safety Population.

Blood samples were collected at indicated time points for the analysis of hematology parameter erythrocytes mean corpuscular hemoglobin. Baseline is defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, within each treatment.

Outcome measures

Outcome measures
Measure	Portia (0.3 mg EE/ 0.15 mg LNG) n=23 Participants Participants in period 1 received Portia (0.3 mg of EE and 0.15 mg LNG) QD on Day 1 through Day 10.	Portia (0.3 mg EE/ 0.15 mg LNG)+GSK3640254 Participants in treatment period 2 were co-administered with GSK3640254 200 mg QD along with Portia from Day 11 through Day 21.
Period 1: Absolute Values of Hematology Parameter: Erythrocytes Mean Corpuscular Hemoglobin Baseline	29.70 Picograms Standard Deviation 2.010	—
Period 1: Absolute Values of Hematology Parameter: Erythrocytes Mean Corpuscular Hemoglobin Day 10	29.62 Picograms Standard Deviation 2.228	—

SECONDARY outcome

Timeframe: Baseline (Day 10) and at Days 21 and 24

Population: Safety Population. Only those participants with data available at specified time points were analyzed (represented by n=X in the category titles).

Blood samples were collected at indicated time points for the analysis of hematology parameter erythrocytes mean corpuscular hemoglobin. Baseline is defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, within each treatment.

Outcome measures

Outcome measures
Measure	Portia (0.3 mg EE/ 0.15 mg LNG) n=21 Participants Participants in period 1 received Portia (0.3 mg of EE and 0.15 mg LNG) QD on Day 1 through Day 10.	Portia (0.3 mg EE/ 0.15 mg LNG)+GSK3640254 Participants in treatment period 2 were co-administered with GSK3640254 200 mg QD along with Portia from Day 11 through Day 21.
Period 2: Absolute Values of Hematology Parameter: Erythrocytes Mean Corpuscular Hemoglobin Baseline, n=21	29.92 Picograms Standard Deviation 2.068	—
Period 2: Absolute Values of Hematology Parameter: Erythrocytes Mean Corpuscular Hemoglobin Day 21, n=17	29.72 Picograms Standard Deviation 1.779	—
Period 2: Absolute Values of Hematology Parameter: Erythrocytes Mean Corpuscular Hemoglobin Day 24, n=17	30.12 Picograms Standard Deviation 1.867	—

SECONDARY outcome

Timeframe: Baseline (Day 1, Pre-dose) and at Day 10

Population: Safety Population.

Blood samples were collected at indicated time points for the analysis of hematology parameter erythrocytes mean corpuscular volume. Baseline is defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, within each treatment.

Outcome measures

Outcome measures
Measure	Portia (0.3 mg EE/ 0.15 mg LNG) n=23 Participants Participants in period 1 received Portia (0.3 mg of EE and 0.15 mg LNG) QD on Day 1 through Day 10.	Portia (0.3 mg EE/ 0.15 mg LNG)+GSK3640254 Participants in treatment period 2 were co-administered with GSK3640254 200 mg QD along with Portia from Day 11 through Day 21.
Period 1: Absolute Values of Hematology Parameter: Erythrocytes Mean Corpuscular Volume Baseline	87.83 Femtoliters Standard Deviation 5.060	—
Period 1: Absolute Values of Hematology Parameter: Erythrocytes Mean Corpuscular Volume Day 10	87.65 Femtoliters Standard Deviation 4.991	—

SECONDARY outcome

Timeframe: Baseline (Day 10) and at Days 21 and 24

Population: Safety Population. Only those participants with data available at specified time points were analyzed (represented by n=X in the category titles).

Blood samples were collected at indicated time points for the analysis of hematology parameter erythrocytes mean corpuscular volume. Baseline is defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, within each treatment.

Outcome measures

Outcome measures
Measure	Portia (0.3 mg EE/ 0.15 mg LNG) n=21 Participants Participants in period 1 received Portia (0.3 mg of EE and 0.15 mg LNG) QD on Day 1 through Day 10.	Portia (0.3 mg EE/ 0.15 mg LNG)+GSK3640254 Participants in treatment period 2 were co-administered with GSK3640254 200 mg QD along with Portia from Day 11 through Day 21.
Period 2: Absolute Values of Hematology Parameter: Erythrocytes Mean Corpuscular Volume Baseline, n=21	88.16 Femtoliters Standard Deviation 4.889	—
Period 2: Absolute Values of Hematology Parameter: Erythrocytes Mean Corpuscular Volume Day 21, n=17	88.39 Femtoliters Standard Deviation 4.293	—
Period 2: Absolute Values of Hematology Parameter: Erythrocytes Mean Corpuscular Volume Day 24, n=17	88.92 Femtoliters Standard Deviation 4.278	—

SECONDARY outcome

Timeframe: Baseline (Day 1, Pre-dose) and at Day 10

Population: Safety Population.

Blood samples were collected at indicated time points for the analysis of hematology parameter erythrocytes. Baseline is defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, within each treatment.

Outcome measures

Outcome measures
Measure	Portia (0.3 mg EE/ 0.15 mg LNG) n=23 Participants Participants in period 1 received Portia (0.3 mg of EE and 0.15 mg LNG) QD on Day 1 through Day 10.	Portia (0.3 mg EE/ 0.15 mg LNG)+GSK3640254 Participants in treatment period 2 were co-administered with GSK3640254 200 mg QD along with Portia from Day 11 through Day 21.
Period 1: Absolute Values of Hematology Parameter: Erythrocytes Baseline	4.316 10^12 cells per liter Standard Deviation 0.3113	—
Period 1: Absolute Values of Hematology Parameter: Erythrocytes Day 10	4.306 10^12 cells per liter Standard Deviation 0.3008	—

SECONDARY outcome

Timeframe: Baseline (Day 10) and at Days 21 and 24

Population: Safety Population. Only those participants with data available at specified time points were analyzed (represented by n=X in the category titles).

Blood samples were collected at indicated time points for the analysis of hematology parameter erythrocytes. Baseline is defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, within each treatment.

Outcome measures

Outcome measures
Measure	Portia (0.3 mg EE/ 0.15 mg LNG) n=21 Participants Participants in period 1 received Portia (0.3 mg of EE and 0.15 mg LNG) QD on Day 1 through Day 10.	Portia (0.3 mg EE/ 0.15 mg LNG)+GSK3640254 Participants in treatment period 2 were co-administered with GSK3640254 200 mg QD along with Portia from Day 11 through Day 21.
Period 2: Absolute Values of Hematology Parameter: Erythrocytes Baseline, n=21	4.308 10^12 cells per liter Standard Deviation 0.3103	—
Period 2: Absolute Values of Hematology Parameter: Erythrocytes Day 21, n=17	4.356 10^12 cells per liter Standard Deviation 0.2518	—
Period 2: Absolute Values of Hematology Parameter: Erythrocytes Day 24, n=17	4.383 10^12 cells per liter Standard Deviation 0.2998	—

SECONDARY outcome

Timeframe: Baseline (Day 1, Pre-dose) and at Day 10

Population: Safety Population.

Blood samples were collected at indicated time points for the analysis of hematology parameter hematocrit. Baseline is defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, within each treatment.

Outcome measures

Outcome measures
Measure	Portia (0.3 mg EE/ 0.15 mg LNG) n=23 Participants Participants in period 1 received Portia (0.3 mg of EE and 0.15 mg LNG) QD on Day 1 through Day 10.	Portia (0.3 mg EE/ 0.15 mg LNG)+GSK3640254 Participants in treatment period 2 were co-administered with GSK3640254 200 mg QD along with Portia from Day 11 through Day 21.
Period 1: Absolute Values of Hematology Parameter: Hematocrit Baseline	0.3783 Proportion of red blood cells in blood Standard Deviation 0.02759	—
Period 1: Absolute Values of Hematology Parameter: Hematocrit Day 10	0.3769 Proportion of red blood cells in blood Standard Deviation 0.02467	—

SECONDARY outcome

Timeframe: Baseline (Day 10) and at Days 21 and 24

Population: Safety Population. Only those participants with data available at specified time points were analyzed (represented by n=X in the category titles).

Blood samples were collected at indicated time points for the analysis of hematology parameter hematocrit. Baseline is defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, within each treatment.

Outcome measures

Outcome measures
Measure	Portia (0.3 mg EE/ 0.15 mg LNG) n=21 Participants Participants in period 1 received Portia (0.3 mg of EE and 0.15 mg LNG) QD on Day 1 through Day 10.	Portia (0.3 mg EE/ 0.15 mg LNG)+GSK3640254 Participants in treatment period 2 were co-administered with GSK3640254 200 mg QD along with Portia from Day 11 through Day 21.
Period 2: Absolute Values of Hematology Parameter: Hematocrit Baseline, n=21	0.3791 Proportion of red blood cells in blood Standard Deviation 0.02457	—
Period 2: Absolute Values of Hematology Parameter: Hematocrit Day 21, n=17	0.3848 Proportion of red blood cells in blood Standard Deviation 0.02650	—
Period 2: Absolute Values of Hematology Parameter: Hematocrit Day 24, n=17	0.3895 Proportion of red blood cells in blood Standard Deviation 0.02969	—

SECONDARY outcome

Timeframe: Baseline (Day 1, Pre-dose) and at Day 10

Population: Safety Population.

Blood samples were collected at indicated time points for the analysis of hematology parameter hemoglobin. Baseline is defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, within each treatment.

Outcome measures

Outcome measures
Measure	Portia (0.3 mg EE/ 0.15 mg LNG) n=23 Participants Participants in period 1 received Portia (0.3 mg of EE and 0.15 mg LNG) QD on Day 1 through Day 10.	Portia (0.3 mg EE/ 0.15 mg LNG)+GSK3640254 Participants in treatment period 2 were co-administered with GSK3640254 200 mg QD along with Portia from Day 11 through Day 21.
Period 1: Absolute Values of Hematology Parameter: Hemoglobin Baseline	128.0 Grams per liter Standard Deviation 10.06	—
Period 1: Absolute Values of Hematology Parameter: Hemoglobin Day 10	127.2 Grams per liter Standard Deviation 9.29	—

SECONDARY outcome

Timeframe: Baseline (Day 10) and at Days 21 and 24

Population: Safety Population. Only those participants with data available at specified time points were analyzed (represented by n=X in the category titles).

Blood samples were collected at indicated time points for the analysis of hematology parameter hemoglobin. Baseline is defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, within each treatment.

Outcome measures

Outcome measures
Measure	Portia (0.3 mg EE/ 0.15 mg LNG) n=21 Participants Participants in period 1 received Portia (0.3 mg of EE and 0.15 mg LNG) QD on Day 1 through Day 10.	Portia (0.3 mg EE/ 0.15 mg LNG)+GSK3640254 Participants in treatment period 2 were co-administered with GSK3640254 200 mg QD along with Portia from Day 11 through Day 21.
Period 2: Absolute Values of Hematology Parameter: Hemoglobin Baseline, n=21	128.5 Grams per liter Standard Deviation 8.61	—
Period 2: Absolute Values of Hematology Parameter: Hemoglobin Day 21, n=17	129.5 Grams per liter Standard Deviation 10.22	—
Period 2: Absolute Values of Hematology Parameter: Hemoglobin Day 24, n=17	132.1 Grams per liter Standard Deviation 11.23	—

SECONDARY outcome

Timeframe: Baseline (Day 1, Pre-dose) and at Day 10

Population: Safety Population.

Urine samples were collected at indicated time points for the assessment of specific gravity. Urine specific gravity is a measure of the concentration of solutes in the urine and provides information on the kidney's ability to concentrate urine. The concentration of the excreted molecules determines the urine's specific gravity. Baseline is defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, within each treatment.

Outcome measures

Outcome measures
Measure	Portia (0.3 mg EE/ 0.15 mg LNG) n=23 Participants Participants in period 1 received Portia (0.3 mg of EE and 0.15 mg LNG) QD on Day 1 through Day 10.	Portia (0.3 mg EE/ 0.15 mg LNG)+GSK3640254 Participants in treatment period 2 were co-administered with GSK3640254 200 mg QD along with Portia from Day 11 through Day 21.
Period 1: Absolute Values of Urine Concentration: Urine Specific Gravity Baseline	1.0136 Ratio Standard Deviation 0.00693	—
Period 1: Absolute Values of Urine Concentration: Urine Specific Gravity Day 10	1.0159 Ratio Standard Deviation 0.00766	—

SECONDARY outcome

Timeframe: Baseline (Day 10) and at Days 21 and 24

Population: Safety Population. Only those participants with data available at specified time points were analyzed (represented by n=X in the category titles).

Urine samples were collected at indicated time points for the assessment of specific gravity. Urine specific gravity is a measure of the concentration of solutes in the urine and provides information on the kidney's ability to concentrate urine. The concentration of the excreted molecules determines the urine's specific gravity. Baseline is defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, within each treatment.

Outcome measures

Outcome measures
Measure	Portia (0.3 mg EE/ 0.15 mg LNG) n=21 Participants Participants in period 1 received Portia (0.3 mg of EE and 0.15 mg LNG) QD on Day 1 through Day 10.	Portia (0.3 mg EE/ 0.15 mg LNG)+GSK3640254 Participants in treatment period 2 were co-administered with GSK3640254 200 mg QD along with Portia from Day 11 through Day 21.
Period 2: Absolute Values of Urine Concentration: Urine Specific Gravity Baseline, n=21	1.0162 Ratio Standard Deviation 0.00792	—
Period 2: Absolute Values of Urine Concentration: Urine Specific Gravity Day 21, n=18	1.0134 Ratio Standard Deviation 0.00982	—
Period 2: Absolute Values of Urine Concentration: Urine Specific Gravity Day 24, n=17	1.0139 Ratio Standard Deviation 0.00807	—

SECONDARY outcome

Timeframe: Baseline (Day 1, Pre-dose) and at Day 10

Population: Safety Population.

Urine samples were collected at indicated time points for the assessment of urine urobilinogen. Baseline is defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, within each treatment.

Outcome measures

Outcome measures
Measure	Portia (0.3 mg EE/ 0.15 mg LNG) n=23 Participants Participants in period 1 received Portia (0.3 mg of EE and 0.15 mg LNG) QD on Day 1 through Day 10.	Portia (0.3 mg EE/ 0.15 mg LNG)+GSK3640254 Participants in treatment period 2 were co-administered with GSK3640254 200 mg QD along with Portia from Day 11 through Day 21.
Period 1: Absolute Values of Urine Concentration: Urine Urobilinogen Baseline	3.3860 Micromoles per liter Standard Deviation 0.00000	—
Period 1: Absolute Values of Urine Concentration: Urine Urobilinogen Day 10	5.1526 Micromoles per liter Standard Deviation 4.66388	—

SECONDARY outcome

Timeframe: Baseline (Day 10) and at Days 21 and 24

Population: Safety Population. Only those participants with data available at specified time points were analyzed (represented by n=X in the category titles).

Urine samples were collected at indicated time points for the assessment of urine urobilinogen. Baseline is defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, within each treatment.

Outcome measures

Outcome measures
Measure	Portia (0.3 mg EE/ 0.15 mg LNG) n=21 Participants Participants in period 1 received Portia (0.3 mg of EE and 0.15 mg LNG) QD on Day 1 through Day 10.	Portia (0.3 mg EE/ 0.15 mg LNG)+GSK3640254 Participants in treatment period 2 were co-administered with GSK3640254 200 mg QD along with Portia from Day 11 through Day 21.
Period 2: Absolute Values of Urine Concentration: Urine Urobilinogen Baseline, n=21	5.3209 Micromoles per liter Standard Deviation 4.85645	—
Period 2: Absolute Values of Urine Concentration: Urine Urobilinogen Day 21, n=18	7.9007 Micromoles per liter Standard Deviation 6.56981	—
Period 2: Absolute Values of Urine Concentration: Urine Urobilinogen Day 24, n=17	4.1827 Micromoles per liter Standard Deviation 3.28490	—

SECONDARY outcome

Timeframe: Baseline (Day 1, Pre-dose) and at Day 10

Population: Safety Population.

Urine samples were collected at indicated time points for the assessment of Urinary pH. Urine pH is an acid-base measurement. pH is measured on a numeric scale ranging from 0 to 14; values on the scale refer to the degree of alkalinity or acidity. A pH of 7 is neutral. A pH less than 7 is acidic, and a pH greater than 7 is basic. Normal urine has a slightly acid pH (5.0 - 6.0). Baseline is defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, within each treatment.

Outcome measures

Outcome measures
Measure	Portia (0.3 mg EE/ 0.15 mg LNG) n=23 Participants Participants in period 1 received Portia (0.3 mg of EE and 0.15 mg LNG) QD on Day 1 through Day 10.	Portia (0.3 mg EE/ 0.15 mg LNG)+GSK3640254 Participants in treatment period 2 were co-administered with GSK3640254 200 mg QD along with Portia from Day 11 through Day 21.
Period 1: Absolute Values of Urine Concentration: Urine pH Baseline	6.09 pH Standard Deviation 0.468	—
Period 1: Absolute Values of Urine Concentration: Urine pH Day 10	5.87 pH Standard Deviation 0.310	—

SECONDARY outcome

Timeframe: Baseline (Day 10) and at Days 21 and 24

Population: Safety Population. Only those participants with data available at specified time points were analyzed (represented by n=X in the category titles).

Urine samples were collected at indicated time points for the assessment of Urinary pH. Urine pH is an acid-base measurement. pH is measured on a numeric scale ranging from 0 to 14; values on the scale refer to the degree of alkalinity or acidity. A pH of 7 is neutral. A pH less than 7 is acidic, and a pH greater than 7 is basic. Normal urine has a slightly acid pH (5.0 - 6.0). Baseline is defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, within each treatment.

Outcome measures

Outcome measures
Measure	Portia (0.3 mg EE/ 0.15 mg LNG) n=21 Participants Participants in period 1 received Portia (0.3 mg of EE and 0.15 mg LNG) QD on Day 1 through Day 10.	Portia (0.3 mg EE/ 0.15 mg LNG)+GSK3640254 Participants in treatment period 2 were co-administered with GSK3640254 200 mg QD along with Portia from Day 11 through Day 21.
Period 2: Absolute Values of Urine Concentration: Urine pH Baseline, n=21	5.88 pH Standard Deviation 0.312	—
Period 2: Absolute Values of Urine Concentration: Urine pH Day 21, n=18	6.28 pH Standard Deviation 0.428	—
Period 2: Absolute Values of Urine Concentration: Urine pH Day 24, n=17	6.12 pH Standard Deviation 0.219	—

SECONDARY outcome

Timeframe: Baseline (Day 1, Pre-dose) and at Day 10

Population: Safety Population.

The dipstick test gives results in a semi-quantitative manner and results for urinalysis parameters (ketones, glucose, bilirubin, occult blood, nitrite and blood protein) can be read as positive, trace, 1+, 2+, 3+ and 4+ indicating proportional concentrations in the urine sample. Only participants with abnormal findings for urinalysis at any visit has been presented.

Outcome measures

Outcome measures
Measure	Portia (0.3 mg EE/ 0.15 mg LNG) n=23 Participants Participants in period 1 received Portia (0.3 mg of EE and 0.15 mg LNG) QD on Day 1 through Day 10.	Portia (0.3 mg EE/ 0.15 mg LNG)+GSK3640254 Participants in treatment period 2 were co-administered with GSK3640254 200 mg QD along with Portia from Day 11 through Day 21.
Period 1: Number of Participants With Abnormal Urinalysis Parameters Using Dipstick Method. Urine Ketone, Day 10, Trace	1 Participants	—
Period 1: Number of Participants With Abnormal Urinalysis Parameters Using Dipstick Method. Urine Ketone, Day 10, 1+	1 Participants	—
Period 1: Number of Participants With Abnormal Urinalysis Parameters Using Dipstick Method. Urine leukocyte esterase, Day 10, 1+	2 Participants	—
Period 1: Number of Participants With Abnormal Urinalysis Parameters Using Dipstick Method. Urine Nitrite, Baseline, Positive	1 Participants	—
Period 1: Number of Participants With Abnormal Urinalysis Parameters Using Dipstick Method. Urine occult blood, Baseline, 1+	1 Participants	—
Period 1: Number of Participants With Abnormal Urinalysis Parameters Using Dipstick Method. Urine occult blood, Baseline, 2+	2 Participants	—
Period 1: Number of Participants With Abnormal Urinalysis Parameters Using Dipstick Method. Urine occult blood, Baseline, 3+	2 Participants	—
Period 1: Number of Participants With Abnormal Urinalysis Parameters Using Dipstick Method. Urine occult blood, Day 10, Trace	1 Participants	—
Period 1: Number of Participants With Abnormal Urinalysis Parameters Using Dipstick Method. Urine occult blood, Day 10, 1+	2 Participants	—
Period 1: Number of Participants With Abnormal Urinalysis Parameters Using Dipstick Method. Urine occult blood, Day 10, 3+	1 Participants	—
Period 1: Number of Participants With Abnormal Urinalysis Parameters Using Dipstick Method. Urine protein, Day 10, Trace	1 Participants	—

SECONDARY outcome

Timeframe: Baseline (Day 10) and at Days 21 and 24

Population: Safety Population.

The dipstick test gives results in a semi-quantitative manner and results for urinalysis parameters (ketones, glucose, bilirubin, occult blood, nitrite and blood protein) can be read as positive, trace, 1+, 2+, 3+ and 4+ indicating proportional concentrations in the urine sample. Only participants with abnormal findings for urinalysis at any visit has been presented.

Outcome measures

Outcome measures
Measure	Portia (0.3 mg EE/ 0.15 mg LNG) n=21 Participants Participants in period 1 received Portia (0.3 mg of EE and 0.15 mg LNG) QD on Day 1 through Day 10.	Portia (0.3 mg EE/ 0.15 mg LNG)+GSK3640254 Participants in treatment period 2 were co-administered with GSK3640254 200 mg QD along with Portia from Day 11 through Day 21.
Period 2: Number of Participants With Abnormal Urinalysis Parameters Using Dipstick Method. Urine Ketone, Baseline, Trace	1 Participants	—
Period 2: Number of Participants With Abnormal Urinalysis Parameters Using Dipstick Method. Urine Ketone, Baseline, 1+	1 Participants	—
Period 2: Number of Participants With Abnormal Urinalysis Parameters Using Dipstick Method. Urine Ketone, Day 21, Trace	1 Participants	—
Period 2: Number of Participants With Abnormal Urinalysis Parameters Using Dipstick Method. Urine Ketone, Day 24, 2+	1 Participants	—
Period 2: Number of Participants With Abnormal Urinalysis Parameters Using Dipstick Method. Urine leukocyte esterase, Baseline, 1+	2 Participants	—
Period 2: Number of Participants With Abnormal Urinalysis Parameters Using Dipstick Method. Urine leukocyte esterase, Day 21, 1+	1 Participants	—
Period 2: Number of Participants With Abnormal Urinalysis Parameters Using Dipstick Method. Urine Nitrite, Day 21, Positive	1 Participants	—
Period 2: Number of Participants With Abnormal Urinalysis Parameters Using Dipstick Method. Urine Nitrite, Day 24, Positive	1 Participants	—
Period 2: Number of Participants With Abnormal Urinalysis Parameters Using Dipstick Method. Urine occult blood, Baseline, Trace	1 Participants	—
Period 2: Number of Participants With Abnormal Urinalysis Parameters Using Dipstick Method. Urine occult blood, Baseline, 1+	2 Participants	—
Period 2: Number of Participants With Abnormal Urinalysis Parameters Using Dipstick Method. Urine occult blood, Baseline, 3+	1 Participants	—
Period 2: Number of Participants With Abnormal Urinalysis Parameters Using Dipstick Method. Urine occult blood, Day 21, Trace	3 Participants	—
Period 2: Number of Participants With Abnormal Urinalysis Parameters Using Dipstick Method. Urine occult blood, Day 21, 3+	1 Participants	—
Period 2: Number of Participants With Abnormal Urinalysis Parameters Using Dipstick Method. Urine occult blood, Day 24, Trace	1 Participants	—
Period 2: Number of Participants With Abnormal Urinalysis Parameters Using Dipstick Method. Urine occult blood, Day 24, 1+	2 Participants	—
Period 2: Number of Participants With Abnormal Urinalysis Parameters Using Dipstick Method. Urine occult blood, Day 24, 2+	1 Participants	—
Period 2: Number of Participants With Abnormal Urinalysis Parameters Using Dipstick Method. Urine occult blood, Day 24, 3+	1 Participants	—
Period 2: Number of Participants With Abnormal Urinalysis Parameters Using Dipstick Method. Urine Protein, Baseline, Trace	1 Participants	—

SECONDARY outcome

Timeframe: Baseline (Day 1, Pre-dose) and at Day 10

Population: Safety Population.

Twelve-lead ECGs were performed with the participant in a supine or semi-supine position after a rest of at least 10 minutes using an automated ECG machine to measure heart rate. Baseline is defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, within each treatment.

Outcome measures

Outcome measures
Measure	Portia (0.3 mg EE/ 0.15 mg LNG) n=23 Participants Participants in period 1 received Portia (0.3 mg of EE and 0.15 mg LNG) QD on Day 1 through Day 10.	Portia (0.3 mg EE/ 0.15 mg LNG)+GSK3640254 Participants in treatment period 2 were co-administered with GSK3640254 200 mg QD along with Portia from Day 11 through Day 21.
Period 1: Absolute Values of ECG Mean Heart Rate Baseline	67.9 Beats per minute Standard Deviation 10.09	—
Period 1: Absolute Values of ECG Mean Heart Rate Day 10	67.0 Beats per minute Standard Deviation 7.07	—

SECONDARY outcome

Timeframe: Baseline (Day 11, Pre-dose) and at Day 11: 2, 4, 6 hours, Day 15: 2, 4, 6 hours, Day 21 and 24

Population: Safety Population. Only those participants with data available at specified time points were analyzed (represented by n=X in the category titles).

Twelve-lead ECGs were performed with the participant in a supine or semi-supine position after a rest of at least 10 minutes using an automated ECG machine to measure heart rate. Baseline is defined as the average of the triplicate predose assessments on Day 11.

Outcome measures

Outcome measures
Measure	Portia (0.3 mg EE/ 0.15 mg LNG) n=21 Participants Participants in period 1 received Portia (0.3 mg of EE and 0.15 mg LNG) QD on Day 1 through Day 10.	Portia (0.3 mg EE/ 0.15 mg LNG)+GSK3640254 Participants in treatment period 2 were co-administered with GSK3640254 200 mg QD along with Portia from Day 11 through Day 21.
Period 2: Absolute Values of ECG Mean Heart Rate Day 15: 2 hours, n=18	67.9 Beats per minute Standard Deviation 9.42	—
Period 2: Absolute Values of ECG Mean Heart Rate Baseline, n=21	64.6 Beats per minute Standard Deviation 8.49	—
Period 2: Absolute Values of ECG Mean Heart Rate Day 11: 2 hours, n=21	67.4 Beats per minute Standard Deviation 7.89	—
Period 2: Absolute Values of ECG Mean Heart Rate Day 11: 4 hours, n=21	64.0 Beats per minute Standard Deviation 6.73	—
Period 2: Absolute Values of ECG Mean Heart Rate Day 11: 6 hours, n=21	71.3 Beats per minute Standard Deviation 7.59	—
Period 2: Absolute Values of ECG Mean Heart Rate Day 15: 4 hours, n=18	65.8 Beats per minute Standard Deviation 9.53	—
Period 2: Absolute Values of ECG Mean Heart Rate Day 15: 6 hours, n=18	67.2 Beats per minute Standard Deviation 8.80	—
Period 2: Absolute Values of ECG Mean Heart Rate Day 21, n=18	67.8 Beats per minute Standard Deviation 7.72	—
Period 2: Absolute Values of ECG Mean Heart Rate Day 24, n=17	64.5 Beats per minute Standard Deviation 7.41	—

SECONDARY outcome

Timeframe: Baseline (Day 1, Pre-dose) and at Day 10

Population: Safety Population.

Twelve-lead ECGs were performed with the participant in a supine or semi-supine position after a rest of at least 10 minutes using an automated ECG machine to measure PR interval, QRS duration, QT Interval, QTcF Interval and QTcB interval. Baseline is defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, within each treatment.

Outcome measures

Outcome measures
Measure	Portia (0.3 mg EE/ 0.15 mg LNG) n=23 Participants Participants in period 1 received Portia (0.3 mg of EE and 0.15 mg LNG) QD on Day 1 through Day 10.	Portia (0.3 mg EE/ 0.15 mg LNG)+GSK3640254 Participants in treatment period 2 were co-administered with GSK3640254 200 mg QD along with Portia from Day 11 through Day 21.
Period 1: Absolute Values of ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF Interval, and QTcB Interval PR interval, Baseline	156.1 Milliseconds Standard Deviation 20.37	—
Period 1: Absolute Values of ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF Interval, and QTcB Interval PR interval, Day 10	158.6 Milliseconds Standard Deviation 19.93	—
Period 1: Absolute Values of ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF Interval, and QTcB Interval QRS duration, Baseline	85.7 Milliseconds Standard Deviation 9.86	—
Period 1: Absolute Values of ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF Interval, and QTcB Interval QRS duration, Day 10	85.9 Milliseconds Standard Deviation 8.81	—
Period 1: Absolute Values of ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF Interval, and QTcB Interval QT interval, Baseline	389.8 Milliseconds Standard Deviation 22.39	—
Period 1: Absolute Values of ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF Interval, and QTcB Interval QT interval, Day 10	386.8 Milliseconds Standard Deviation 19.95	—
Period 1: Absolute Values of ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF Interval, and QTcB Interval QTcF interval, Baseline	404.7 Milliseconds Standard Deviation 13.56	—
Period 1: Absolute Values of ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF Interval, and QTcB Interval QTcF interval, Day 10	400.6 Milliseconds Standard Deviation 12.77	—
Period 1: Absolute Values of ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF Interval, and QTcB Interval QTcB interval, Baseline	412.0 Milliseconds Standard Deviation 18.41	—
Period 1: Absolute Values of ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF Interval, and QTcB Interval QTcB interval, Day 10	407.4 Milliseconds Standard Deviation 14.28	—

SECONDARY outcome

Timeframe: Baseline (Day 11, Pre-dose) and at Day 11- 2, 4, 6 hours, Day 15- 2, 4, 6 hours, Day 21 and 24

Population: Safety Population. Only those participants with data available at specified time points were analyzed (represented by n=X in the category titles).

Twelve-lead ECGs were performed with the participant in a supine or semi-supine position after a rest of at least 10 minutes using an automated ECG machine to measure PR Interval, QRS Duration, QT Interval, QTcF and QTcB Interval. Baseline is defined as the average of the triplicate predose assessments on Day 11.

Outcome measures

Outcome measures
Measure	Portia (0.3 mg EE/ 0.15 mg LNG) n=21 Participants Participants in period 1 received Portia (0.3 mg of EE and 0.15 mg LNG) QD on Day 1 through Day 10.	Portia (0.3 mg EE/ 0.15 mg LNG)+GSK3640254 Participants in treatment period 2 were co-administered with GSK3640254 200 mg QD along with Portia from Day 11 through Day 21.
Period 2: Absolute Values of ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF and QTcB Interval PR interval, Day 15: 2 hours, n=18	158.7 Milliseconds Standard Deviation 21.29	—
Period 2: Absolute Values of ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF and QTcB Interval PR interval, Day 15: 4 hours, n=18	159.8 Milliseconds Standard Deviation 17.11	—
Period 2: Absolute Values of ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF and QTcB Interval PR interval, Baseline, n=21	159.1 Milliseconds Standard Deviation 18.22	—
Period 2: Absolute Values of ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF and QTcB Interval PR interval, Day 11: 2 hours, n=21	159.4 Milliseconds Standard Deviation 19.73	—
Period 2: Absolute Values of ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF and QTcB Interval PR interval, Day 11: 4 hours, n=21	161.0 Milliseconds Standard Deviation 18.73	—
Period 2: Absolute Values of ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF and QTcB Interval PR interval, Day 11: 6 hours, n=21	157.2 Milliseconds Standard Deviation 20.08	—
Period 2: Absolute Values of ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF and QTcB Interval PR interval, Day 15: 6 hours, n=18	158.1 Milliseconds Standard Deviation 17.46	—
Period 2: Absolute Values of ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF and QTcB Interval PR interval, Day 21, n=18	162.1 Milliseconds Standard Deviation 18.06	—
Period 2: Absolute Values of ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF and QTcB Interval PR interval, Day 24, n=17	162.8 Milliseconds Standard Deviation 15.26	—
Period 2: Absolute Values of ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF and QTcB Interval QRS duration, Baseline, n=21	85.5 Milliseconds Standard Deviation 7.40	—
Period 2: Absolute Values of ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF and QTcB Interval QRS duration, Day 11: 2 hours, n=21	83.3 Milliseconds Standard Deviation 6.57	—
Period 2: Absolute Values of ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF and QTcB Interval QRS duration, Day 11: 4 hours, n=21	84.9 Milliseconds Standard Deviation 10.17	—
Period 2: Absolute Values of ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF and QTcB Interval QRS duration, Day 11: 6 hours, n=21	85.2 Milliseconds Standard Deviation 8.05	—
Period 2: Absolute Values of ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF and QTcB Interval QRS duration, Day 15: 2 hours, n=18	84.8 Milliseconds Standard Deviation 6.68	—
Period 2: Absolute Values of ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF and QTcB Interval QRS duration, Day 15: 4 hours, n=18	84.6 Milliseconds Standard Deviation 8.33	—
Period 2: Absolute Values of ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF and QTcB Interval QRS duration, Day 15: 6 hours, n=18	83.6 Milliseconds Standard Deviation 8.44	—
Period 2: Absolute Values of ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF and QTcB Interval QRS duration, Day 21, n=18	84.1 Milliseconds Standard Deviation 9.46	—
Period 2: Absolute Values of ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF and QTcB Interval QRS duration, Day 24, n=17	83.5 Milliseconds Standard Deviation 8.60	—
Period 2: Absolute Values of ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF and QTcB Interval QT interval, Baseline, n=21	394.2 Milliseconds Standard Deviation 22.09	—
Period 2: Absolute Values of ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF and QTcB Interval QT interval, Day 11: 2 hours, n=21	377.8 Milliseconds Standard Deviation 20.18	—
Period 2: Absolute Values of ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF and QTcB Interval QT interval, Day 11: 4 hours, n=21	396.5 Milliseconds Standard Deviation 21.88	—
Period 2: Absolute Values of ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF and QTcB Interval QT interval, Day 11: 6 hours, n=21	382.5 Milliseconds Standard Deviation 22.01	—
Period 2: Absolute Values of ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF and QTcB Interval QT interval, Day 15: 2 hours, n=18	382.9 Milliseconds Standard Deviation 18.90	—
Period 2: Absolute Values of ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF and QTcB Interval QT interval, Day 15: 4 hours, n=18	392.8 Milliseconds Standard Deviation 24.36	—
Period 2: Absolute Values of ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF and QTcB Interval QT interval, Day 15: 6 hours, n=18	395.3 Milliseconds Standard Deviation 25.60	—
Period 2: Absolute Values of ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF and QTcB Interval QT interval, Day 21, n=18	385.7 Milliseconds Standard Deviation 25.68	—
Period 2: Absolute Values of ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF and QTcB Interval QT interval, Day 24, n=17	394.2 Milliseconds Standard Deviation 22.25	—
Period 2: Absolute Values of ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF and QTcB Interval QTcF interval, Baseline, n=21	403.2 Milliseconds Standard Deviation 12.93	—
Period 2: Absolute Values of ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF and QTcB Interval QTcF interval, Day 11: 2 hours, n=21	391.8 Milliseconds Standard Deviation 10.63	—
Period 2: Absolute Values of ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF and QTcB Interval QTcF interval, Day 11: 4 hours, n=21	404.6 Milliseconds Standard Deviation 12.78	—
Period 2: Absolute Values of ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF and QTcB Interval QTcF interval, Day 11: 6 hours, n=21	404.5 Milliseconds Standard Deviation 14.13	—
Period 2: Absolute Values of ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF and QTcB Interval QTcF interval, Day 15: 2 hours, n=18	398.2 Milliseconds Standard Deviation 11.51	—
Period 2: Absolute Values of ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF and QTcB Interval QTcF interval, Day 15: 4 hours, n=18	403.6 Milliseconds Standard Deviation 11.73	—
Period 2: Absolute Values of ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF and QTcB Interval QTcF interval, Day 15: 6 hours, n=18	409.3 Milliseconds Standard Deviation 12.19	—
Period 2: Absolute Values of ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF and QTcB Interval QTcF interval, Day 21, n=18	400.8 Milliseconds Standard Deviation 13.69	—
Period 2: Absolute Values of ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF and QTcB Interval QTcF interval, Day 24, n=17	403.0 Milliseconds Standard Deviation 12.02	—
Period 2: Absolute Values of ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF and QTcB Interval QTcB interval, Baseline, n=21	407.2 Milliseconds Standard Deviation 16.45	—
Period 2: Absolute Values of ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF and QTcB Interval QTcB interval, Day 11: 2 hours, n=21	398.7 Milliseconds Standard Deviation 12.38	—
Period 2: Absolute Values of ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF and QTcB Interval QTcB interval, Day 11: 4 hours, n=21	408.2 Milliseconds Standard Deviation 12.46	—
Period 2: Absolute Values of ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF and QTcB Interval QTcB interval, Day 11: 6 hours, n=21	415.4 Milliseconds Standard Deviation 15.09	—
Period 2: Absolute Values of ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF and QTcB Interval QTcB interval, Day 15: 2 hours, n=18	405.5 Milliseconds Standard Deviation 16.82	—
Period 2: Absolute Values of ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF and QTcB Interval QTcB interval, Day 15: 4 hours, n=18	408.8 Milliseconds Standard Deviation 13.73	—
Period 2: Absolute Values of ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF and QTcB Interval QTcB interval, Day 15: 6 hours, n=18	415.9 Milliseconds Standard Deviation 11.36	—
Period 2: Absolute Values of ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF and QTcB Interval QTcB interval, Day 21, n=18	407.9 Milliseconds Standard Deviation 11.29	—
Period 2: Absolute Values of ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF and QTcB Interval QTcB interval, Day 24, n=17	407.2 Milliseconds Standard Deviation 12.99	—

SECONDARY outcome

Timeframe: Baseline (Day 1, Pre-dose) and at Day 10

Population: Safety Population.

SBP and DBP were assessed in the semi-recumbent position with a completely automated device at indicated time-points. Baseline is defined as the average of the triplicate predose assessments on Day 11.

Outcome measures

Outcome measures
Measure	Portia (0.3 mg EE/ 0.15 mg LNG) n=23 Participants Participants in period 1 received Portia (0.3 mg of EE and 0.15 mg LNG) QD on Day 1 through Day 10.	Portia (0.3 mg EE/ 0.15 mg LNG)+GSK3640254 Participants in treatment period 2 were co-administered with GSK3640254 200 mg QD along with Portia from Day 11 through Day 21.
Period 1: Absolute Values of Vital Signs: SBP and DBP SBP, Baseline	115.7 Millimeters of mercury Standard Deviation 8.50	—
Period 1: Absolute Values of Vital Signs: SBP and DBP SBP, Day 10	111.4 Millimeters of mercury Standard Deviation 12.58	—
Period 1: Absolute Values of Vital Signs: SBP and DBP DBP, Baseline	71.9 Millimeters of mercury Standard Deviation 8.87	—
Period 1: Absolute Values of Vital Signs: SBP and DBP DBP, Day 10	69.1 Millimeters of mercury Standard Deviation 8.71	—

SECONDARY outcome

Timeframe: Baseline (Day 11, Pre-dose) and at Days 15, 21 and 24

Population: Safety Population. Only those participants with data available at specified time points were analyzed (represented by n=X in the category titles).

SBP and DBP were assessed in the semi-recumbent position with a completely automated device at indicated time-points. Baseline is defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, within each treatment.

Outcome measures

Outcome measures
Measure	Portia (0.3 mg EE/ 0.15 mg LNG) n=21 Participants Participants in period 1 received Portia (0.3 mg of EE and 0.15 mg LNG) QD on Day 1 through Day 10.	Portia (0.3 mg EE/ 0.15 mg LNG)+GSK3640254 Participants in treatment period 2 were co-administered with GSK3640254 200 mg QD along with Portia from Day 11 through Day 21.
Period 2: Absolute Values of Vital Signs: SBP and DBP SBP, Baseline, n=21	110.0 Millimeters of mercury Standard Deviation 8.24	—
Period 2: Absolute Values of Vital Signs: SBP and DBP SBP, Day 15, n=19	113.3 Millimeters of mercury Standard Deviation 6.63	—
Period 2: Absolute Values of Vital Signs: SBP and DBP SBP, Day 21, n=18	110.1 Millimeters of mercury Standard Deviation 5.22	—
Period 2: Absolute Values of Vital Signs: SBP and DBP SBP, Day 24, n=17	114.5 Millimeters of mercury Standard Deviation 7.00	—
Period 2: Absolute Values of Vital Signs: SBP and DBP DBP, Baseline, n=21	64.6 Millimeters of mercury Standard Deviation 7.69	—
Period 2: Absolute Values of Vital Signs: SBP and DBP DBP, Day 15, n=19	66.7 Millimeters of mercury Standard Deviation 5.85	—
Period 2: Absolute Values of Vital Signs: SBP and DBP DBP, Day 21, n=18	67.4 Millimeters of mercury Standard Deviation 6.01	—
Period 2: Absolute Values of Vital Signs: SBP and DBP DBP, Day 24, n=17	69.7 Millimeters of mercury Standard Deviation 6.63	—

SECONDARY outcome

Timeframe: Baseline (Day 1, Pre-dose) and at Day 10

Population: Safety Population.

Pulse rate was assessed in the semi-recumbent position with a completely automated device at indicated time-points. Baseline is defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, within each treatment.

Outcome measures

Outcome measures
Measure	Portia (0.3 mg EE/ 0.15 mg LNG) n=23 Participants Participants in period 1 received Portia (0.3 mg of EE and 0.15 mg LNG) QD on Day 1 through Day 10.	Portia (0.3 mg EE/ 0.15 mg LNG)+GSK3640254 Participants in treatment period 2 were co-administered with GSK3640254 200 mg QD along with Portia from Day 11 through Day 21.
Period 1: Absolute Values of Pulse Rate Baseline	70.1 Beats per minute Standard Deviation 10.20	—
Period 1: Absolute Values of Pulse Rate Day 10	70.0 Beats per minute Standard Deviation 9.28	—

SECONDARY outcome

Timeframe: Baseline (Day 11, Pre-dose) and at Days 15, 21 and 24

Population: Safety Population. Only those participants with data available at specified time points were analyzed (represented by n=X in the category titles).

Pulse rate was assessed in the semi-recumbent position with a completely automated device at indicated time-points. Baseline is defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, within each treatment.

Outcome measures

Outcome measures
Measure	Portia (0.3 mg EE/ 0.15 mg LNG) n=21 Participants Participants in period 1 received Portia (0.3 mg of EE and 0.15 mg LNG) QD on Day 1 through Day 10.	Portia (0.3 mg EE/ 0.15 mg LNG)+GSK3640254 Participants in treatment period 2 were co-administered with GSK3640254 200 mg QD along with Portia from Day 11 through Day 21.
Period 2: Absolute Values of Pulse Rate Baseline, n=21	69.2 Beats per minute Standard Deviation 12.19	—
Period 2: Absolute Values of Pulse Rate Day 15, n=19	73.5 Beats per minute Standard Deviation 8.62	—
Period 2: Absolute Values of Pulse Rate Day 21, n=18	69.4 Beats per minute Standard Deviation 7.11	—
Period 2: Absolute Values of Pulse Rate Day 24, n=17	68.4 Beats per minute Standard Deviation 7.63	—

SECONDARY outcome

Timeframe: Baseline (Day 1, Pre-dose) and at Day 10

Population: Safety Population.

Respiratory rate was assessed indicated time-points. Baseline is defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, within each treatment.

Outcome measures

Outcome measures
Measure	Portia (0.3 mg EE/ 0.15 mg LNG) n=23 Participants Participants in period 1 received Portia (0.3 mg of EE and 0.15 mg LNG) QD on Day 1 through Day 10.	Portia (0.3 mg EE/ 0.15 mg LNG)+GSK3640254 Participants in treatment period 2 were co-administered with GSK3640254 200 mg QD along with Portia from Day 11 through Day 21.
Period 1: Absolute Values of Respiratory Rate Baseline	13.6 Breaths per minute Standard Deviation 2.56	—
Period 1: Absolute Values of Respiratory Rate Day 10	15.8 Breaths per minute Standard Deviation 2.33	—

SECONDARY outcome

Timeframe: Baseline (Day 11, Pre-dose) and at Days 15, 21 and 24

Population: Safety Population. Only those participants with data available at specified time points were analyzed (represented by n=X in the category titles).

Respiratory rate was assessed indicated time-points. Baseline is defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, within each treatment.

Outcome measures

Outcome measures
Measure	Portia (0.3 mg EE/ 0.15 mg LNG) n=21 Participants Participants in period 1 received Portia (0.3 mg of EE and 0.15 mg LNG) QD on Day 1 through Day 10.	Portia (0.3 mg EE/ 0.15 mg LNG)+GSK3640254 Participants in treatment period 2 were co-administered with GSK3640254 200 mg QD along with Portia from Day 11 through Day 21.
Period 2: Absolute Values of Respiratory Rate Baseline, n=21	13.2 Breaths per minute Standard Deviation 2.41	—
Period 2: Absolute Values of Respiratory Rate Day 15, n=19	15.1 Breaths per minute Standard Deviation 2.93	—
Period 2: Absolute Values of Respiratory Rate Day 21, n=18	14.1 Breaths per minute Standard Deviation 1.88	—
Period 2: Absolute Values of Respiratory Rate Day 24, n=17	14.5 Breaths per minute Standard Deviation 2.60	—

SECONDARY outcome

Timeframe: Baseline (Day 1, Pre-dose) and at Day 10

Population: Safety Population.

Temperature was assessed at indicated time-points. Baseline is defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, within each treatment.

Outcome measures

Outcome measures
Measure	Portia (0.3 mg EE/ 0.15 mg LNG) n=23 Participants Participants in period 1 received Portia (0.3 mg of EE and 0.15 mg LNG) QD on Day 1 through Day 10.	Portia (0.3 mg EE/ 0.15 mg LNG)+GSK3640254 Participants in treatment period 2 were co-administered with GSK3640254 200 mg QD along with Portia from Day 11 through Day 21.
Period 1: Absolute Values of Temperature Baseline	36.66 Degree Celsius Standard Deviation 0.487	—
Period 1: Absolute Values of Temperature Day 10	36.77 Degree Celsius Standard Deviation 0.335	—

SECONDARY outcome

Timeframe: Baseline (Day 11, Pre-dose) and at Days 15, 21 and 24

Population: Safety Population. Only those participants with data available at specified time points were analyzed (represented by n=X in the category titles).

Temperature was assessed at indicated time-points. Baseline is defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, within each treatment.

Outcome measures

Outcome measures
Measure	Portia (0.3 mg EE/ 0.15 mg LNG) n=21 Participants Participants in period 1 received Portia (0.3 mg of EE and 0.15 mg LNG) QD on Day 1 through Day 10.	Portia (0.3 mg EE/ 0.15 mg LNG)+GSK3640254 Participants in treatment period 2 were co-administered with GSK3640254 200 mg QD along with Portia from Day 11 through Day 21.
Period 2: Absolute Values of Temperature Baseline, n=21	36.60 Degree Celsius Standard Deviation 0.434	—
Period 2: Absolute Values of Temperature Day 15, n=19	36.75 Degree Celsius Standard Deviation 0.391	—
Period 2: Absolute Values of Temperature Day 21, n=18	36.59 Degree Celsius Standard Deviation 0.424	—
Period 2: Absolute Values of Temperature Day 24, n=17	36.82 Degree Celsius Standard Deviation 0.481	—

Adverse Events

Portia - Run-in Period (Day -3 to Day -1)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Portia (0.3 mg EE/ 0.15 mg LNG)

Serious events: 0 serious events

Other events: 5 other events

Deaths: 0 deaths

Portia (0.3 mg EE/ 0.15 mg LNG)+GSK3640254

Serious events: 0 serious events

Other events: 9 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Portia - Run-in Period (Day -3 to Day -1) n=23 participants at risk Participants in Run-in period received Portia (0.03 mg EE/0.15 mg LNG) QD on Day -3 through Day -1.	Portia (0.3 mg EE/ 0.15 mg LNG) n=23 participants at risk Participants in period 1 received Portia (0.3 mg of EE and 0.15 mg LNG) QD on Day 1 through Day 10.	Portia (0.3 mg EE/ 0.15 mg LNG)+GSK3640254 n=21 participants at risk Participants in treatment period 2 were co-administered with GSK3640254 200 mg QD along with Portia from Day 11 through Day 21.
Investigations Transaminases increased	0.00% 0/23 • Non-serious AEs and SAEs were collected from Day -3 to Day -1 in Run-in period and up to Day 25 in Treatment period. Non-serious AEs and SAEs were reported for the safety population which comprised of all participants who received at least one dose of study medication.	17.4% 4/23 • Non-serious AEs and SAEs were collected from Day -3 to Day -1 in Run-in period and up to Day 25 in Treatment period. Non-serious AEs and SAEs were reported for the safety population which comprised of all participants who received at least one dose of study medication.	4.8% 1/21 • Non-serious AEs and SAEs were collected from Day -3 to Day -1 in Run-in period and up to Day 25 in Treatment period. Non-serious AEs and SAEs were reported for the safety population which comprised of all participants who received at least one dose of study medication.
Nervous system disorders Headache	0.00% 0/23 • Non-serious AEs and SAEs were collected from Day -3 to Day -1 in Run-in period and up to Day 25 in Treatment period. Non-serious AEs and SAEs were reported for the safety population which comprised of all participants who received at least one dose of study medication.	0.00% 0/23 • Non-serious AEs and SAEs were collected from Day -3 to Day -1 in Run-in period and up to Day 25 in Treatment period. Non-serious AEs and SAEs were reported for the safety population which comprised of all participants who received at least one dose of study medication.	19.0% 4/21 • Non-serious AEs and SAEs were collected from Day -3 to Day -1 in Run-in period and up to Day 25 in Treatment period. Non-serious AEs and SAEs were reported for the safety population which comprised of all participants who received at least one dose of study medication.
Gastrointestinal disorders Abdominal pain	0.00% 0/23 • Non-serious AEs and SAEs were collected from Day -3 to Day -1 in Run-in period and up to Day 25 in Treatment period. Non-serious AEs and SAEs were reported for the safety population which comprised of all participants who received at least one dose of study medication.	4.3% 1/23 • Non-serious AEs and SAEs were collected from Day -3 to Day -1 in Run-in period and up to Day 25 in Treatment period. Non-serious AEs and SAEs were reported for the safety population which comprised of all participants who received at least one dose of study medication.	4.8% 1/21 • Non-serious AEs and SAEs were collected from Day -3 to Day -1 in Run-in period and up to Day 25 in Treatment period. Non-serious AEs and SAEs were reported for the safety population which comprised of all participants who received at least one dose of study medication.
Gastrointestinal disorders Diarrhoea	0.00% 0/23 • Non-serious AEs and SAEs were collected from Day -3 to Day -1 in Run-in period and up to Day 25 in Treatment period. Non-serious AEs and SAEs were reported for the safety population which comprised of all participants who received at least one dose of study medication.	0.00% 0/23 • Non-serious AEs and SAEs were collected from Day -3 to Day -1 in Run-in period and up to Day 25 in Treatment period. Non-serious AEs and SAEs were reported for the safety population which comprised of all participants who received at least one dose of study medication.	9.5% 2/21 • Non-serious AEs and SAEs were collected from Day -3 to Day -1 in Run-in period and up to Day 25 in Treatment period. Non-serious AEs and SAEs were reported for the safety population which comprised of all participants who received at least one dose of study medication.
Gastrointestinal disorders Infrequent bowel movements	0.00% 0/23 • Non-serious AEs and SAEs were collected from Day -3 to Day -1 in Run-in period and up to Day 25 in Treatment period. Non-serious AEs and SAEs were reported for the safety population which comprised of all participants who received at least one dose of study medication.	0.00% 0/23 • Non-serious AEs and SAEs were collected from Day -3 to Day -1 in Run-in period and up to Day 25 in Treatment period. Non-serious AEs and SAEs were reported for the safety population which comprised of all participants who received at least one dose of study medication.	9.5% 2/21 • Non-serious AEs and SAEs were collected from Day -3 to Day -1 in Run-in period and up to Day 25 in Treatment period. Non-serious AEs and SAEs were reported for the safety population which comprised of all participants who received at least one dose of study medication.
Reproductive system and breast disorders Metrorrhagia	0.00% 0/23 • Non-serious AEs and SAEs were collected from Day -3 to Day -1 in Run-in period and up to Day 25 in Treatment period. Non-serious AEs and SAEs were reported for the safety population which comprised of all participants who received at least one dose of study medication.	8.7% 2/23 • Non-serious AEs and SAEs were collected from Day -3 to Day -1 in Run-in period and up to Day 25 in Treatment period. Non-serious AEs and SAEs were reported for the safety population which comprised of all participants who received at least one dose of study medication.	4.8% 1/21 • Non-serious AEs and SAEs were collected from Day -3 to Day -1 in Run-in period and up to Day 25 in Treatment period. Non-serious AEs and SAEs were reported for the safety population which comprised of all participants who received at least one dose of study medication.
Skin and subcutaneous tissue disorders Pruritus	0.00% 0/23 • Non-serious AEs and SAEs were collected from Day -3 to Day -1 in Run-in period and up to Day 25 in Treatment period. Non-serious AEs and SAEs were reported for the safety population which comprised of all participants who received at least one dose of study medication.	0.00% 0/23 • Non-serious AEs and SAEs were collected from Day -3 to Day -1 in Run-in period and up to Day 25 in Treatment period. Non-serious AEs and SAEs were reported for the safety population which comprised of all participants who received at least one dose of study medication.	9.5% 2/21 • Non-serious AEs and SAEs were collected from Day -3 to Day -1 in Run-in period and up to Day 25 in Treatment period. Non-serious AEs and SAEs were reported for the safety population which comprised of all participants who received at least one dose of study medication.

Additional Information

GSK Response Center

ViiV Healthcare

Phone: 866-435-7343

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
Publication restrictions are in place

Restriction type: OTHER