Trial Outcomes & Findings for A Study of Effects of Itraconazole and Rifampin on Selpercatinib (LY3527723) in Healthy Participants (NCT NCT05338489)
NCT ID: NCT05338489
Last Updated: 2025-09-19
Results Overview
PK: AUC0-t of Selpercatinib was reported. Outcome measure timeframe: Parts 1 and 2, Period 1: (Day 1) Pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144, 168 hours post dose. Part 1, Period 2; (Day 1) pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144, 168 hours post dose. (contd.)
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
24 participants
Primary outcome timeframe
(contd.) Part 2, Period 2: (Day 1) pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 hours post dose; (Day 10) Pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144, 168 hours post dose.
Results posted on
2025-09-19
Participant Flow
Participant milestones
| Measure |
Part 1 - 160 mg Selpercatinib + 200 mg Itraconazole
Participants received a single oral dose of 160 milligrams (mg) selpercatinib on Day 1 of Period 1.
In Period 2, participants received an oral dose of 200 mg itraconazole administered once daily (QD) for 11 consecutive days (Days -4 to 7) with a single oral dose of 160 mg selpercatinib co-administered on Day 1 of Period 2.
There was a washout period of at least 7 days between the dose of selpercatinib in Period 1 and the first dose of itraconazole in Period 2.
|
Part 2 - 160 mg Selpercatinib + 600 mg Rifampin
Participants received a single oral dose of 160 mg selpercatinib on Day 1 of Period 1.
In Period 2, participants received an oral dose of 600 mg rifampin administered QD for 16 consecutive days (Days 1 to 16) with a single oral dose of 160 mg selpercatinib co-administered on Day 1 and Day 10 of Period 2.
There was a washout period of at least 7 days between the dose of selpercatinib in Period 1 and the first dose of rifampin and selpercatinib in Period 2.
|
|---|---|---|
|
Period 1
STARTED
|
12
|
12
|
|
Period 1
Received at Least One Dose of Study Drug
|
12
|
12
|
|
Period 1
COMPLETED
|
12
|
12
|
|
Period 1
NOT COMPLETED
|
0
|
0
|
|
Period 2
STARTED
|
12
|
12
|
|
Period 2
Received at Least One Dose of Study Drug
|
12
|
12
|
|
Period 2
COMPLETED
|
12
|
12
|
|
Period 2
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Study of Effects of Itraconazole and Rifampin on Selpercatinib (LY3527723) in Healthy Participants
Baseline characteristics by cohort
| Measure |
Part 1 - 160 mg Selpercatinib + 200 mg Itraconazole
n=12 Participants
Participants received a single oral dose of 160 mg selpercatinib on Day 1 of Period 1.
In Period 2, participants received an oral dose of 200 mg itraconazole administered QD for 11 consecutive days (Days -4 to 7) with a single oral dose of 160 mg selpercatinib co-administered on Day 1 of Period 2.
There was a washout period of at least 7 days between the dose of selpercatinib in Period 1 and the first dose of itraconazole in Period 2.
|
Part 2 - 160 mg Selpercatinib + 600 mg Rifampin
n=12 Participants
Participants received a single oral dose of 160 mg selpercatinib on Day 1 of Period 1.
In Period 2, participants received an oral dose of 600 mg rifampin administered QD for 16 consecutive days (Days 1 to 16) with a single oral dose of 160 mg selpercatinib co-administered on Day 1 and Day 10 of Period 2.
There was a washout period of at least 7 days between the dose of selpercatinib in Period 1 and the first dose of rifampin and selpercatinib in Period 2.
|
Total
n=24 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
40.3 years
STANDARD_DEVIATION 7.81 • n=5 Participants
|
37.8 years
STANDARD_DEVIATION 7.15 • n=7 Participants
|
39.1 years
STANDARD_DEVIATION 7.43 • n=5 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
8 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
4 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
10 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
12 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: (contd.) Part 2, Period 2: (Day 1) pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 hours post dose; (Day 10) Pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144, 168 hours post dose.Population: All participants who received at least one dose of selpercatinib with evaluable PK data.
PK: AUC0-t of Selpercatinib was reported. Outcome measure timeframe: Parts 1 and 2, Period 1: (Day 1) Pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144, 168 hours post dose. Part 1, Period 2; (Day 1) pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144, 168 hours post dose. (contd.)
Outcome measures
| Measure |
Part 1 Period 1: 160 mg Selpercatinib
n=12 Participants
Participants received a single oral dose of 160 mg selpercatinib on Day 1 of Period 1.
|
Part 1 Period 2: 160 mg Selpercatinib + 200 mg Itraconazole
n=12 Participants
Participants received an oral dose of 200 mg itraconazole administered QD for 11 consecutive days (Days -4 to 7) with a single oral dose of 160 mg selpercatinib co-administered on Day 1 of Period 2.
|
Part 2 Period 1: 160 mg Selpercatinib
n=12 Participants
Participants received a single oral dose of 160 mg selpercatinib on Day 1 of Period 1.
|
Part 2 Period 2: 160 mg Selpercatinib on Day 1 + 600 mg Rifampin
n=12 Participants
Participants received an oral dose of 600 mg rifampin administered QD for 16 consecutive days (Days 1 to 16) with a single oral dose of 160 mg selpercatinib co-administered on Day 1 of Period 2.
|
Part 2 Period 2: 160 mg Selpercatinib on Day 10 + 600 mg Rifampin
n=12 Participants
Participants received an oral dose of 600 mg rifampin administered QD for 16 consecutive days (Days 1 to 16) with a single oral dose of 160 mg selpercatinib co-administered on Day 10 of Period 2.
|
|---|---|---|---|---|---|
|
Pharmacokinetics (PK): Area Under the Concentration-time Curve, From Time 0 to the Last Observed Non-zero Concentration (AUC0-t) of Selpercatinib
|
22380 nanogram *hour per milliliter (ng*h/mL)
Geometric Coefficient of Variation 31.8
|
51570 nanogram *hour per milliliter (ng*h/mL)
Geometric Coefficient of Variation 41.9
|
21070 nanogram *hour per milliliter (ng*h/mL)
Geometric Coefficient of Variation 24.4
|
14080 nanogram *hour per milliliter (ng*h/mL)
Geometric Coefficient of Variation 39.2
|
2784 nanogram *hour per milliliter (ng*h/mL)
Geometric Coefficient of Variation 39.1
|
PRIMARY outcome
Timeframe: (contd.) Part 2, Period 2: (Day 1) pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 hours post dose; (Day 10) Pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144, 168 hours post dose.Population: All participants who received at least one dose of selpercatinib with evaluable PK data.
PK: AUC0-inf of Selpercatinib was reported. Outcome measure timeframe: Parts 1 and 2, Period 1: (Day 1) Pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144, 168 hours post dose. Part 1, Period 2; (Day 1) pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144, 168 hours post dose. (contd.)
Outcome measures
| Measure |
Part 1 Period 1: 160 mg Selpercatinib
n=12 Participants
Participants received a single oral dose of 160 mg selpercatinib on Day 1 of Period 1.
|
Part 1 Period 2: 160 mg Selpercatinib + 200 mg Itraconazole
n=12 Participants
Participants received an oral dose of 200 mg itraconazole administered QD for 11 consecutive days (Days -4 to 7) with a single oral dose of 160 mg selpercatinib co-administered on Day 1 of Period 2.
|
Part 2 Period 1: 160 mg Selpercatinib
n=12 Participants
Participants received a single oral dose of 160 mg selpercatinib on Day 1 of Period 1.
|
Part 2 Period 2: 160 mg Selpercatinib on Day 1 + 600 mg Rifampin
n=12 Participants
Participants received an oral dose of 600 mg rifampin administered QD for 16 consecutive days (Days 1 to 16) with a single oral dose of 160 mg selpercatinib co-administered on Day 1 of Period 2.
|
Part 2 Period 2: 160 mg Selpercatinib on Day 10 + 600 mg Rifampin
n=12 Participants
Participants received an oral dose of 600 mg rifampin administered QD for 16 consecutive days (Days 1 to 16) with a single oral dose of 160 mg selpercatinib co-administered on Day 10 of Period 2.
|
|---|---|---|---|---|---|
|
PK: Area Under the Concentration-time Curve From Time 0 Extrapolated to Infinity (AUC0-inf) of Selpercatinib
|
22490 ng*hr/mL
Geometric Coefficient of Variation 31.4
|
52450 ng*hr/mL
Geometric Coefficient of Variation 41.6
|
21180 ng*hr/mL
Geometric Coefficient of Variation 23.9
|
16310 ng*hr/mL
Geometric Coefficient of Variation 33.4
|
2820 ng*hr/mL
Geometric Coefficient of Variation 38.9
|
PRIMARY outcome
Timeframe: (contd.) Part 2, Period 2: (Day 1) pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 hours post dose; (Day 10) Pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144, 168 hours post dose.Population: All participants who received at least one dose of selpercatinib with evaluable PK data.
PK: AUC%extrap of Selpercatinib was reported. Outcome measure timeframe: Parts 1 and 2, Period 1: (Day 1) Pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144, 168 hours post dose. Part 1, Period 2; (Day 1) pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144, 168 hours post dose. (contd.)
Outcome measures
| Measure |
Part 1 Period 1: 160 mg Selpercatinib
n=12 Participants
Participants received a single oral dose of 160 mg selpercatinib on Day 1 of Period 1.
|
Part 1 Period 2: 160 mg Selpercatinib + 200 mg Itraconazole
n=12 Participants
Participants received an oral dose of 200 mg itraconazole administered QD for 11 consecutive days (Days -4 to 7) with a single oral dose of 160 mg selpercatinib co-administered on Day 1 of Period 2.
|
Part 2 Period 1: 160 mg Selpercatinib
n=12 Participants
Participants received a single oral dose of 160 mg selpercatinib on Day 1 of Period 1.
|
Part 2 Period 2: 160 mg Selpercatinib on Day 1 + 600 mg Rifampin
n=12 Participants
Participants received an oral dose of 600 mg rifampin administered QD for 16 consecutive days (Days 1 to 16) with a single oral dose of 160 mg selpercatinib co-administered on Day 1 of Period 2.
|
Part 2 Period 2: 160 mg Selpercatinib on Day 10 + 600 mg Rifampin
n=12 Participants
Participants received an oral dose of 600 mg rifampin administered QD for 16 consecutive days (Days 1 to 16) with a single oral dose of 160 mg selpercatinib co-administered on Day 10 of Period 2.
|
|---|---|---|---|---|---|
|
PK: Percentage of AUC0-inf Extrapolated (AUC%Extrap) of Selpercatinib
|
0.3377 percentage of AUC0-inf extrapolated
Geometric Coefficient of Variation 82.1
|
1.531 percentage of AUC0-inf extrapolated
Geometric Coefficient of Variation 48.1
|
0.3405 percentage of AUC0-inf extrapolated
Geometric Coefficient of Variation 98.9
|
12.33 percentage of AUC0-inf extrapolated
Geometric Coefficient of Variation 44.7
|
1.081 percentage of AUC0-inf extrapolated
Geometric Coefficient of Variation 67.9
|
PRIMARY outcome
Timeframe: (contd.) Part 2, Period 2: (Day 1) pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 hours post dose; (Day 10) Pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144, 168 hours post dose.Population: All participants who received at least one dose of selpercatinib with evaluable PK data.
PK: Maximum observed concentration (Cmax) of Selpercatinib was reported. Outcome measure timeframe: Parts 1 and 2, Period 1: (Day 1) Pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144, 168 hours post dose. Part 1, Period 2; (Day 1) pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144, 168 hours post dose.
Outcome measures
| Measure |
Part 1 Period 1: 160 mg Selpercatinib
n=12 Participants
Participants received a single oral dose of 160 mg selpercatinib on Day 1 of Period 1.
|
Part 1 Period 2: 160 mg Selpercatinib + 200 mg Itraconazole
n=12 Participants
Participants received an oral dose of 200 mg itraconazole administered QD for 11 consecutive days (Days -4 to 7) with a single oral dose of 160 mg selpercatinib co-administered on Day 1 of Period 2.
|
Part 2 Period 1: 160 mg Selpercatinib
n=12 Participants
Participants received a single oral dose of 160 mg selpercatinib on Day 1 of Period 1.
|
Part 2 Period 2: 160 mg Selpercatinib on Day 1 + 600 mg Rifampin
n=12 Participants
Participants received an oral dose of 600 mg rifampin administered QD for 16 consecutive days (Days 1 to 16) with a single oral dose of 160 mg selpercatinib co-administered on Day 1 of Period 2.
|
Part 2 Period 2: 160 mg Selpercatinib on Day 10 + 600 mg Rifampin
n=12 Participants
Participants received an oral dose of 600 mg rifampin administered QD for 16 consecutive days (Days 1 to 16) with a single oral dose of 160 mg selpercatinib co-administered on Day 10 of Period 2.
|
|---|---|---|---|---|---|
|
PK: Maximum Observed Concentration (Cmax) of Selpercatinib
|
1442 nanograms per milliliter (ng/mL)
Geometric Coefficient of Variation 79.7
|
1880 nanograms per milliliter (ng/mL)
Geometric Coefficient of Variation 78.0
|
1364 nanograms per milliliter (ng/mL)
Geometric Coefficient of Variation 49.6
|
1624 nanograms per milliliter (ng/mL)
Geometric Coefficient of Variation 52.6
|
411.2 nanograms per milliliter (ng/mL)
Geometric Coefficient of Variation 40.3
|
PRIMARY outcome
Timeframe: (contd.) Part 2, Period 2: (Day 1) pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 hours post dose; (Day 10) Pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144, 168 hours post dose.Population: All participants who received at least one dose of selpercatinib with evaluable PK data.
PK: Tmax of Selpercatinib was reported. Outcome measure timeframe: Parts 1 and 2, Period 1: (Day 1) Pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144, 168 hours post dose. Part 1, Period 2; (Day 1) pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144, 168 hours post dose. (contd.)
Outcome measures
| Measure |
Part 1 Period 1: 160 mg Selpercatinib
n=12 Participants
Participants received a single oral dose of 160 mg selpercatinib on Day 1 of Period 1.
|
Part 1 Period 2: 160 mg Selpercatinib + 200 mg Itraconazole
n=12 Participants
Participants received an oral dose of 200 mg itraconazole administered QD for 11 consecutive days (Days -4 to 7) with a single oral dose of 160 mg selpercatinib co-administered on Day 1 of Period 2.
|
Part 2 Period 1: 160 mg Selpercatinib
n=12 Participants
Participants received a single oral dose of 160 mg selpercatinib on Day 1 of Period 1.
|
Part 2 Period 2: 160 mg Selpercatinib on Day 1 + 600 mg Rifampin
n=12 Participants
Participants received an oral dose of 600 mg rifampin administered QD for 16 consecutive days (Days 1 to 16) with a single oral dose of 160 mg selpercatinib co-administered on Day 1 of Period 2.
|
Part 2 Period 2: 160 mg Selpercatinib on Day 10 + 600 mg Rifampin
n=12 Participants
Participants received an oral dose of 600 mg rifampin administered QD for 16 consecutive days (Days 1 to 16) with a single oral dose of 160 mg selpercatinib co-administered on Day 10 of Period 2.
|
|---|---|---|---|---|---|
|
PK: Time to Reach Cmax (Tmax) of Selpercatinib
|
1.502 hours (h)
Interval 1.0 to 24.01
|
1.502 hours (h)
Interval 1.5 to 23.92
|
1.500 hours (h)
Interval 1.0 to 8.03
|
2.003 hours (h)
Interval 1.5 to 3.01
|
1.503 hours (h)
Interval 1.0 to 2.5
|
PRIMARY outcome
Timeframe: (contd.) Part 2, Period 2: (Day 1) pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 hours post dose; (Day 10) Pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144, 168 hours post dose.Population: All participants who received at least one dose of selpercatinib with evaluable PK data.
PK: Kel of Selpercatinib was reported. Outcome measure timeframe: Parts 1 and 2, Period 1: (Day 1) Pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144, 168 hours post dose. Part 1, Period 2; (Day 1) pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144, 168 hours post dose. (contd.)
Outcome measures
| Measure |
Part 1 Period 1: 160 mg Selpercatinib
n=12 Participants
Participants received a single oral dose of 160 mg selpercatinib on Day 1 of Period 1.
|
Part 1 Period 2: 160 mg Selpercatinib + 200 mg Itraconazole
n=12 Participants
Participants received an oral dose of 200 mg itraconazole administered QD for 11 consecutive days (Days -4 to 7) with a single oral dose of 160 mg selpercatinib co-administered on Day 1 of Period 2.
|
Part 2 Period 1: 160 mg Selpercatinib
n=12 Participants
Participants received a single oral dose of 160 mg selpercatinib on Day 1 of Period 1.
|
Part 2 Period 2: 160 mg Selpercatinib on Day 1 + 600 mg Rifampin
n=12 Participants
Participants received an oral dose of 600 mg rifampin administered QD for 16 consecutive days (Days 1 to 16) with a single oral dose of 160 mg selpercatinib co-administered on Day 1 of Period 2.
|
Part 2 Period 2: 160 mg Selpercatinib on Day 10 + 600 mg Rifampin
n=12 Participants
Participants received an oral dose of 600 mg rifampin administered QD for 16 consecutive days (Days 1 to 16) with a single oral dose of 160 mg selpercatinib co-administered on Day 10 of Period 2.
|
|---|---|---|---|---|---|
|
PK: Apparent First-order Terminal Elimination Rate Constant (Kel) of Selpercatinib
|
0.03428 1/hour
Standard Deviation 0.0047764
|
0.02493 1/hour
Standard Deviation 0.0026203
|
0.03567 1/hour
Standard Deviation 0.0080627
|
0.08861 1/hour
Standard Deviation 0.017055
|
0.06487 1/hour
Standard Deviation 0.021752
|
PRIMARY outcome
Timeframe: (contd.) Part 2, Period 2: (Day 1) pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 hours post dose; (Day 10) Pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144, 168 hours post dose.Population: All participants who received at least one dose of selpercatinib with evaluable PK data.
PK: CL/F of Selpercatinib was reported. Outcome measure timeframe: Parts 1 and 2, Period 1: (Day 1) Pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144, 168 hours post dose. Part 1, Period 2; (Day 1) pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144, 168 hours post dose. (contd.)
Outcome measures
| Measure |
Part 1 Period 1: 160 mg Selpercatinib
n=12 Participants
Participants received a single oral dose of 160 mg selpercatinib on Day 1 of Period 1.
|
Part 1 Period 2: 160 mg Selpercatinib + 200 mg Itraconazole
n=12 Participants
Participants received an oral dose of 200 mg itraconazole administered QD for 11 consecutive days (Days -4 to 7) with a single oral dose of 160 mg selpercatinib co-administered on Day 1 of Period 2.
|
Part 2 Period 1: 160 mg Selpercatinib
n=12 Participants
Participants received a single oral dose of 160 mg selpercatinib on Day 1 of Period 1.
|
Part 2 Period 2: 160 mg Selpercatinib on Day 1 + 600 mg Rifampin
n=12 Participants
Participants received an oral dose of 600 mg rifampin administered QD for 16 consecutive days (Days 1 to 16) with a single oral dose of 160 mg selpercatinib co-administered on Day 1 of Period 2.
|
Part 2 Period 2: 160 mg Selpercatinib on Day 10 + 600 mg Rifampin
n=12 Participants
Participants received an oral dose of 600 mg rifampin administered QD for 16 consecutive days (Days 1 to 16) with a single oral dose of 160 mg selpercatinib co-administered on Day 10 of Period 2.
|
|---|---|---|---|---|---|
|
PK: Apparent Total Plasma Clearance After Oral (Extravascular) Administration (CL/F) of Selpercatinib
|
7.474 Liters/hour
Standard Deviation 2.8297
|
3.305 Liters/hour
Standard Deviation 1.5199
|
7.758 Liters/hour
Standard Deviation 1.9819
|
10.40 Liters/hour
Standard Deviation 4.5412
|
60.12 Liters/hour
Standard Deviation 20.457
|
PRIMARY outcome
Timeframe: (contd.) Part 2, Period 2: (Day 1) pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 hours post dose; (Day 10) Pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144, 168 hours post dose.Population: All participants who received at least one dose of selpercatinib with evaluable PK data.
PK: t½ of Selpercatinib was reported. Outcome measure timeframe: Parts 1 and 2, Period 1: (Day 1) Pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144, 168 hours post dose. Part 1, Period 2; (Day 1) pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144, 168 hours post dose. (contd.)
Outcome measures
| Measure |
Part 1 Period 1: 160 mg Selpercatinib
n=12 Participants
Participants received a single oral dose of 160 mg selpercatinib on Day 1 of Period 1.
|
Part 1 Period 2: 160 mg Selpercatinib + 200 mg Itraconazole
n=12 Participants
Participants received an oral dose of 200 mg itraconazole administered QD for 11 consecutive days (Days -4 to 7) with a single oral dose of 160 mg selpercatinib co-administered on Day 1 of Period 2.
|
Part 2 Period 1: 160 mg Selpercatinib
n=12 Participants
Participants received a single oral dose of 160 mg selpercatinib on Day 1 of Period 1.
|
Part 2 Period 2: 160 mg Selpercatinib on Day 1 + 600 mg Rifampin
n=12 Participants
Participants received an oral dose of 600 mg rifampin administered QD for 16 consecutive days (Days 1 to 16) with a single oral dose of 160 mg selpercatinib co-administered on Day 1 of Period 2.
|
Part 2 Period 2: 160 mg Selpercatinib on Day 10 + 600 mg Rifampin
n=12 Participants
Participants received an oral dose of 600 mg rifampin administered QD for 16 consecutive days (Days 1 to 16) with a single oral dose of 160 mg selpercatinib co-administered on Day 10 of Period 2.
|
|---|---|---|---|---|---|
|
PK: Apparent First-order Terminal Elimination Half-life (t½) of Selpercatinib
|
20.617 h
Standard Deviation 3.1941
|
28.098 h
Standard Deviation 3.0183
|
20.437 h
Standard Deviation 5.1657
|
8.117 h
Standard Deviation 1.7029
|
12.508 h
Standard Deviation 6.2399
|
PRIMARY outcome
Timeframe: Part 2, Periods 1 and 2: (Day 1) pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 hours post dose.Population: All participants in Part 2 who received at least one dose of selpercatinib on Day 1 of either period with evaluable PK data.
PK: AUC0-24 of Selpercatinib in Part 2 was reported.
Outcome measures
| Measure |
Part 1 Period 1: 160 mg Selpercatinib
n=12 Participants
Participants received a single oral dose of 160 mg selpercatinib on Day 1 of Period 1.
|
Part 1 Period 2: 160 mg Selpercatinib + 200 mg Itraconazole
n=12 Participants
Participants received an oral dose of 200 mg itraconazole administered QD for 11 consecutive days (Days -4 to 7) with a single oral dose of 160 mg selpercatinib co-administered on Day 1 of Period 2.
|
Part 2 Period 1: 160 mg Selpercatinib
Participants received a single oral dose of 160 mg selpercatinib on Day 1 of Period 1.
|
Part 2 Period 2: 160 mg Selpercatinib on Day 1 + 600 mg Rifampin
Participants received an oral dose of 600 mg rifampin administered QD for 16 consecutive days (Days 1 to 16) with a single oral dose of 160 mg selpercatinib co-administered on Day 1 of Period 2.
|
Part 2 Period 2: 160 mg Selpercatinib on Day 10 + 600 mg Rifampin
Participants received an oral dose of 600 mg rifampin administered QD for 16 consecutive days (Days 1 to 16) with a single oral dose of 160 mg selpercatinib co-administered on Day 10 of Period 2.
|
|---|---|---|---|---|---|
|
Part 2 - PK: Area Under the Concentration-Time Curve From Time 0 to 24 Hours (AUC0-24) of Selpercatinib Post Dose Day 1
|
13240 ng*h/mL
Geometric Coefficient of Variation 33.3
|
14090 ng*h/mL
Geometric Coefficient of Variation 39.2
|
—
|
—
|
—
|
Adverse Events
Part 1 Period 1: 160 mg Selpercatinib
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Part 1 Period 2: 160 mg Selpercatinib + 200 mg Itraconazole
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Part 2 Period 1: 160 mg Selpercatinib
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Part 2 Period 2: 160 mg Selpercatinib + 600 mg Rifampin
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Part 1 Period 1: 160 mg Selpercatinib
n=12 participants at risk
Participants received a single oral dose of 160 mg selpercatinib on Day 1 of Period 1.
|
Part 1 Period 2: 160 mg Selpercatinib + 200 mg Itraconazole
n=12 participants at risk
Participants received an oral dose of 200 mg itraconazole administered QD for 11 consecutive days (Days -4 to 7) with a single oral dose of 160 mg selpercatinib co-administered on Day 1 of Period 2.
|
Part 2 Period 1: 160 mg Selpercatinib
n=12 participants at risk
Participants received a single oral dose of 160 mg selpercatinib on Day 1 of Period 1.
|
Part 2 Period 2: 160 mg Selpercatinib + 600 mg Rifampin
n=12 participants at risk
Participants received an oral dose of 600 mg rifampin administered QD for 16 consecutive days (Days 1 to 16) with a single oral dose of 160 mg selpercatinib co-administered on Day 1 and Day 10 of Period 2.
|
|---|---|---|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/12 • Baseline Up To 50 Days
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Per pre-specified analysis, adverse events were reported as per the treatment regimen received.
|
0.00%
0/12 • Baseline Up To 50 Days
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Per pre-specified analysis, adverse events were reported as per the treatment regimen received.
|
0.00%
0/12 • Baseline Up To 50 Days
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Per pre-specified analysis, adverse events were reported as per the treatment regimen received.
|
8.3%
1/12 • Number of events 1 • Baseline Up To 50 Days
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Per pre-specified analysis, adverse events were reported as per the treatment regimen received.
|
|
Gastrointestinal disorders
Abdominal pain lower
|
0.00%
0/12 • Baseline Up To 50 Days
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Per pre-specified analysis, adverse events were reported as per the treatment regimen received.
|
8.3%
1/12 • Number of events 2 • Baseline Up To 50 Days
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Per pre-specified analysis, adverse events were reported as per the treatment regimen received.
|
0.00%
0/12 • Baseline Up To 50 Days
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Per pre-specified analysis, adverse events were reported as per the treatment regimen received.
|
0.00%
0/12 • Baseline Up To 50 Days
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Per pre-specified analysis, adverse events were reported as per the treatment regimen received.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/12 • Baseline Up To 50 Days
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Per pre-specified analysis, adverse events were reported as per the treatment regimen received.
|
8.3%
1/12 • Number of events 1 • Baseline Up To 50 Days
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Per pre-specified analysis, adverse events were reported as per the treatment regimen received.
|
0.00%
0/12 • Baseline Up To 50 Days
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Per pre-specified analysis, adverse events were reported as per the treatment regimen received.
|
0.00%
0/12 • Baseline Up To 50 Days
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Per pre-specified analysis, adverse events were reported as per the treatment regimen received.
|
|
Gastrointestinal disorders
Diarrhoea
|
8.3%
1/12 • Number of events 1 • Baseline Up To 50 Days
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Per pre-specified analysis, adverse events were reported as per the treatment regimen received.
|
0.00%
0/12 • Baseline Up To 50 Days
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Per pre-specified analysis, adverse events were reported as per the treatment regimen received.
|
0.00%
0/12 • Baseline Up To 50 Days
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Per pre-specified analysis, adverse events were reported as per the treatment regimen received.
|
0.00%
0/12 • Baseline Up To 50 Days
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Per pre-specified analysis, adverse events were reported as per the treatment regimen received.
|
|
Gastrointestinal disorders
Lip swelling
|
0.00%
0/12 • Baseline Up To 50 Days
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Per pre-specified analysis, adverse events were reported as per the treatment regimen received.
|
0.00%
0/12 • Baseline Up To 50 Days
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Per pre-specified analysis, adverse events were reported as per the treatment regimen received.
|
8.3%
1/12 • Number of events 2 • Baseline Up To 50 Days
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Per pre-specified analysis, adverse events were reported as per the treatment regimen received.
|
0.00%
0/12 • Baseline Up To 50 Days
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Per pre-specified analysis, adverse events were reported as per the treatment regimen received.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/12 • Baseline Up To 50 Days
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Per pre-specified analysis, adverse events were reported as per the treatment regimen received.
|
0.00%
0/12 • Baseline Up To 50 Days
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Per pre-specified analysis, adverse events were reported as per the treatment regimen received.
|
0.00%
0/12 • Baseline Up To 50 Days
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Per pre-specified analysis, adverse events were reported as per the treatment regimen received.
|
8.3%
1/12 • Number of events 3 • Baseline Up To 50 Days
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Per pre-specified analysis, adverse events were reported as per the treatment regimen received.
|
|
General disorders
Axillary pain
|
0.00%
0/12 • Baseline Up To 50 Days
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Per pre-specified analysis, adverse events were reported as per the treatment regimen received.
|
0.00%
0/12 • Baseline Up To 50 Days
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Per pre-specified analysis, adverse events were reported as per the treatment regimen received.
|
0.00%
0/12 • Baseline Up To 50 Days
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Per pre-specified analysis, adverse events were reported as per the treatment regimen received.
|
8.3%
1/12 • Number of events 2 • Baseline Up To 50 Days
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Per pre-specified analysis, adverse events were reported as per the treatment regimen received.
|
|
General disorders
Nodule
|
0.00%
0/12 • Baseline Up To 50 Days
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Per pre-specified analysis, adverse events were reported as per the treatment regimen received.
|
0.00%
0/12 • Baseline Up To 50 Days
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Per pre-specified analysis, adverse events were reported as per the treatment regimen received.
|
0.00%
0/12 • Baseline Up To 50 Days
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Per pre-specified analysis, adverse events were reported as per the treatment regimen received.
|
8.3%
1/12 • Number of events 1 • Baseline Up To 50 Days
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Per pre-specified analysis, adverse events were reported as per the treatment regimen received.
|
|
Injury, poisoning and procedural complications
Ear canal injury
|
0.00%
0/12 • Baseline Up To 50 Days
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Per pre-specified analysis, adverse events were reported as per the treatment regimen received.
|
0.00%
0/12 • Baseline Up To 50 Days
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Per pre-specified analysis, adverse events were reported as per the treatment regimen received.
|
0.00%
0/12 • Baseline Up To 50 Days
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Per pre-specified analysis, adverse events were reported as per the treatment regimen received.
|
8.3%
1/12 • Number of events 1 • Baseline Up To 50 Days
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Per pre-specified analysis, adverse events were reported as per the treatment regimen received.
|
|
Injury, poisoning and procedural complications
Laceration
|
0.00%
0/12 • Baseline Up To 50 Days
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Per pre-specified analysis, adverse events were reported as per the treatment regimen received.
|
0.00%
0/12 • Baseline Up To 50 Days
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Per pre-specified analysis, adverse events were reported as per the treatment regimen received.
|
0.00%
0/12 • Baseline Up To 50 Days
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Per pre-specified analysis, adverse events were reported as per the treatment regimen received.
|
8.3%
1/12 • Number of events 1 • Baseline Up To 50 Days
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Per pre-specified analysis, adverse events were reported as per the treatment regimen received.
|
|
Investigations
Weight decreased
|
0.00%
0/12 • Baseline Up To 50 Days
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Per pre-specified analysis, adverse events were reported as per the treatment regimen received.
|
0.00%
0/12 • Baseline Up To 50 Days
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Per pre-specified analysis, adverse events were reported as per the treatment regimen received.
|
0.00%
0/12 • Baseline Up To 50 Days
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Per pre-specified analysis, adverse events were reported as per the treatment regimen received.
|
8.3%
1/12 • Number of events 1 • Baseline Up To 50 Days
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Per pre-specified analysis, adverse events were reported as per the treatment regimen received.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/12 • Baseline Up To 50 Days
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Per pre-specified analysis, adverse events were reported as per the treatment regimen received.
|
0.00%
0/12 • Baseline Up To 50 Days
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Per pre-specified analysis, adverse events were reported as per the treatment regimen received.
|
0.00%
0/12 • Baseline Up To 50 Days
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Per pre-specified analysis, adverse events were reported as per the treatment regimen received.
|
8.3%
1/12 • Number of events 1 • Baseline Up To 50 Days
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Per pre-specified analysis, adverse events were reported as per the treatment regimen received.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/12 • Baseline Up To 50 Days
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Per pre-specified analysis, adverse events were reported as per the treatment regimen received.
|
0.00%
0/12 • Baseline Up To 50 Days
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Per pre-specified analysis, adverse events were reported as per the treatment regimen received.
|
0.00%
0/12 • Baseline Up To 50 Days
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Per pre-specified analysis, adverse events were reported as per the treatment regimen received.
|
8.3%
1/12 • Number of events 3 • Baseline Up To 50 Days
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Per pre-specified analysis, adverse events were reported as per the treatment regimen received.
|
|
Nervous system disorders
Headache
|
0.00%
0/12 • Baseline Up To 50 Days
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Per pre-specified analysis, adverse events were reported as per the treatment regimen received.
|
0.00%
0/12 • Baseline Up To 50 Days
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Per pre-specified analysis, adverse events were reported as per the treatment regimen received.
|
8.3%
1/12 • Number of events 1 • Baseline Up To 50 Days
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Per pre-specified analysis, adverse events were reported as per the treatment regimen received.
|
25.0%
3/12 • Number of events 9 • Baseline Up To 50 Days
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Per pre-specified analysis, adverse events were reported as per the treatment regimen received.
|
|
Renal and urinary disorders
Pollakiuria
|
0.00%
0/12 • Baseline Up To 50 Days
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Per pre-specified analysis, adverse events were reported as per the treatment regimen received.
|
8.3%
1/12 • Number of events 1 • Baseline Up To 50 Days
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Per pre-specified analysis, adverse events were reported as per the treatment regimen received.
|
0.00%
0/12 • Baseline Up To 50 Days
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Per pre-specified analysis, adverse events were reported as per the treatment regimen received.
|
0.00%
0/12 • Baseline Up To 50 Days
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Per pre-specified analysis, adverse events were reported as per the treatment regimen received.
|
|
Reproductive system and breast disorders
Dysmenorrhoea
|
0.00%
0/6 • Baseline Up To 50 Days
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Per pre-specified analysis, adverse events were reported as per the treatment regimen received.
|
16.7%
1/6 • Number of events 1 • Baseline Up To 50 Days
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Per pre-specified analysis, adverse events were reported as per the treatment regimen received.
|
0.00%
0/5 • Baseline Up To 50 Days
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Per pre-specified analysis, adverse events were reported as per the treatment regimen received.
|
0.00%
0/5 • Baseline Up To 50 Days
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Per pre-specified analysis, adverse events were reported as per the treatment regimen received.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/12 • Baseline Up To 50 Days
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Per pre-specified analysis, adverse events were reported as per the treatment regimen received.
|
0.00%
0/12 • Baseline Up To 50 Days
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Per pre-specified analysis, adverse events were reported as per the treatment regimen received.
|
8.3%
1/12 • Number of events 1 • Baseline Up To 50 Days
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Per pre-specified analysis, adverse events were reported as per the treatment regimen received.
|
0.00%
0/12 • Baseline Up To 50 Days
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Per pre-specified analysis, adverse events were reported as per the treatment regimen received.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal discomfort
|
0.00%
0/12 • Baseline Up To 50 Days
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Per pre-specified analysis, adverse events were reported as per the treatment regimen received.
|
0.00%
0/12 • Baseline Up To 50 Days
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Per pre-specified analysis, adverse events were reported as per the treatment regimen received.
|
8.3%
1/12 • Number of events 1 • Baseline Up To 50 Days
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Per pre-specified analysis, adverse events were reported as per the treatment regimen received.
|
8.3%
1/12 • Number of events 1 • Baseline Up To 50 Days
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Per pre-specified analysis, adverse events were reported as per the treatment regimen received.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.00%
0/12 • Baseline Up To 50 Days
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Per pre-specified analysis, adverse events were reported as per the treatment regimen received.
|
0.00%
0/12 • Baseline Up To 50 Days
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Per pre-specified analysis, adverse events were reported as per the treatment regimen received.
|
8.3%
1/12 • Number of events 1 • Baseline Up To 50 Days
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Per pre-specified analysis, adverse events were reported as per the treatment regimen received.
|
0.00%
0/12 • Baseline Up To 50 Days
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Per pre-specified analysis, adverse events were reported as per the treatment regimen received.
|
|
Skin and subcutaneous tissue disorders
Seborrhoeic dermatitis
|
8.3%
1/12 • Number of events 3 • Baseline Up To 50 Days
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Per pre-specified analysis, adverse events were reported as per the treatment regimen received.
|
8.3%
1/12 • Number of events 2 • Baseline Up To 50 Days
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Per pre-specified analysis, adverse events were reported as per the treatment regimen received.
|
0.00%
0/12 • Baseline Up To 50 Days
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Per pre-specified analysis, adverse events were reported as per the treatment regimen received.
|
0.00%
0/12 • Baseline Up To 50 Days
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Per pre-specified analysis, adverse events were reported as per the treatment regimen received.
|
|
Vascular disorders
Flushing
|
0.00%
0/12 • Baseline Up To 50 Days
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Per pre-specified analysis, adverse events were reported as per the treatment regimen received.
|
0.00%
0/12 • Baseline Up To 50 Days
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Per pre-specified analysis, adverse events were reported as per the treatment regimen received.
|
8.3%
1/12 • Number of events 1 • Baseline Up To 50 Days
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Per pre-specified analysis, adverse events were reported as per the treatment regimen received.
|
0.00%
0/12 • Baseline Up To 50 Days
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Per pre-specified analysis, adverse events were reported as per the treatment regimen received.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60