Trial Outcomes & Findings for A Study of Baricitinib and Ciclosporin in Healthy Participants (NCT NCT01968057)

NCT ID: NCT01968057

Last Updated: 2017-06-06

Results Overview

Recruitment status

COMPLETED

Study phase

PHASE1

Target enrollment

18 participants

Primary outcome timeframe

Days 1 and 4: predose of baricitinib, 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 36, 48 and 72 hours postdose

Results posted on

2017-06-06

Participant Flow

This was an open-label, 2-period, fixed-sequence study.

Participant milestones

Participant milestones
Measure	Baricitinib + Ciclosporin 4 milligrams (mg) baricitinib administered orally on Day 1 of Period 1. 4 mg baricitinib co-administered with 600 mg ciclosporin on Day 4 of Period 2.
Period 1 (Day 1 to Predosing Day 4) STARTED	18
Period 1 (Day 1 to Predosing Day 4) Received Baricitinib	18
Period 1 (Day 1 to Predosing Day 4) COMPLETED	18
Period 1 (Day 1 to Predosing Day 4) NOT COMPLETED	0
Period 2 (At Dosing Day 4 to Day 7) STARTED	18
Period 2 (At Dosing Day 4 to Day 7) Received Baricitinib + Ciclosporin	18
Period 2 (At Dosing Day 4 to Day 7) COMPLETED	18
Period 2 (At Dosing Day 4 to Day 7) NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

A Study of Baricitinib and Ciclosporin in Healthy Participants

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Baricitinib + Ciclosporin n=18 Participants 4 mg baricitinib administered orally on Day 1 of Period 1. 4 mg baricitinib co-administered with 600 mg ciclosporin on Day 4 of Period 2.
Age, Continuous	38.4 years STANDARD_DEVIATION 12.7 • n=5 Participants
Sex: Female, Male Female	3 Participants n=5 Participants
Sex: Female, Male Male	15 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	18 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	18 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United Kingdom	18 Participants n=5 Participants

PRIMARY outcome

Timeframe: Days 1 and 4: predose of baricitinib, 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 36, 48 and 72 hours postdose

Population: All enrolled participants who received study drug (baricitinib in Period 1 and baricitinib + ciclosporin in Period 2) and had PK data to calculate Cmax of baricitinib.

Outcome measures

Outcome measures
Measure	Baricitinib n=18 Participants 4 mg baricitinib administered orally on Day 1 of Period 1.	Baricitinib + Ciclosporin n=18 Participants 4 mg baricitinib co-administered with 600 mg ciclosporin on Day 4 of Period 2.
Pharmacokinetics (PK): Maximum Concentration (Cmax) of Baricitinib	36.2 nanograms/milliliter (ng/mL) Geometric Coefficient of Variation 25	35.8 nanograms/milliliter (ng/mL) Geometric Coefficient of Variation 22

PRIMARY outcome

Timeframe: Days 1 and 4: predose of baricitinib, 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 36, 48 and 72 hours postdose

Population: All enrolled participants who received study drug (baricitinib in Period 1 and baricitinib + ciclosporin in Period 2) and had PK data to calculate AUC (0-∞) of baricitinib.

Outcome measures

Outcome measures
Measure	Baricitinib n=18 Participants 4 mg baricitinib administered orally on Day 1 of Period 1.	Baricitinib + Ciclosporin n=18 Participants 4 mg baricitinib co-administered with 600 mg ciclosporin on Day 4 of Period 2.
PK: Area Under the Concentration Curve From Time Zero to Infinity [AUC (0-∞)] of Baricitinib	241 nanogramshour/milliliter (ngh/mL) Geometric Coefficient of Variation 24	311 nanogramshour/milliliter (ngh/mL) Geometric Coefficient of Variation 26

PRIMARY outcome

Timeframe: Days 1 and 4: predose of baricitinib, 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 36, 48 and 72 hours postdose

Population: All enrolled participants who received study drug (baricitinib in Period 1 and baricitinib + ciclosporin in Period 2) and had PK data to calculate Tmax of baricitinib.

Outcome measures

Outcome measures
Measure	Baricitinib n=18 Participants 4 mg baricitinib administered orally on Day 1 of Period 1.	Baricitinib + Ciclosporin n=18 Participants 4 mg baricitinib co-administered with 600 mg ciclosporin on Day 4 of Period 2.
PK: Time of Maximum Observed Drug Concentration (Tmax) of Baricitinib	1.00 hours Interval 0.5 to 1.0	2.00 hours Interval 0.5 to 4.0

Adverse Events

Baricitinib

Serious events: 0 serious events

Other events: 9 other events

Deaths: 0 deaths

Baricitinib + Ciclosporin

Serious events: 0 serious events

Other events: 15 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Additional Information

Chief Medical Officer

Eli Lilly and Company

Phone: 800-545-5979

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: GT60

Measure	Baricitinib n=18 participants at risk 4 mg baricitinib administered orally on Day 1 of Period 1. Adverse events are reported from baseline through predose on Day 4.	Baricitinib + Ciclosporin n=18 participants at risk 4 mg baricitinib co-administered with 600 mg ciclosporin on Day 4 of Period 2. Adverse events are reported from postdose on Day 4 up to Day 14.
Gastrointestinal disorders Abdominal pain upper	5.6% 1/18 • Number of events 1 • Baseline through study completion (up to Day 14).	0.00% 0/18 • Baseline through study completion (up to Day 14).
Gastrointestinal disorders Constipation	11.1% 2/18 • Number of events 2 • Baseline through study completion (up to Day 14).	5.6% 1/18 • Number of events 1 • Baseline through study completion (up to Day 14).
Gastrointestinal disorders Defaecation urgency	0.00% 0/18 • Baseline through study completion (up to Day 14).	11.1% 2/18 • Number of events 2 • Baseline through study completion (up to Day 14).
Gastrointestinal disorders Lip dry	0.00% 0/18 • Baseline through study completion (up to Day 14).	5.6% 1/18 • Number of events 1 • Baseline through study completion (up to Day 14).
Gastrointestinal disorders Nausea	0.00% 0/18 • Baseline through study completion (up to Day 14).	44.4% 8/18 • Number of events 8 • Baseline through study completion (up to Day 14).
General disorders Asthenia	0.00% 0/18 • Baseline through study completion (up to Day 14).	5.6% 1/18 • Number of events 1 • Baseline through study completion (up to Day 14).
General disorders Catheter site pain	5.6% 1/18 • Number of events 1 • Baseline through study completion (up to Day 14).	0.00% 0/18 • Baseline through study completion (up to Day 14).
General disorders Catheter site related reaction	0.00% 0/18 • Baseline through study completion (up to Day 14).	11.1% 2/18 • Number of events 2 • Baseline through study completion (up to Day 14).
General disorders Chest pain	0.00% 0/18 • Baseline through study completion (up to Day 14).	5.6% 1/18 • Number of events 1 • Baseline through study completion (up to Day 14).
General disorders Fatigue	0.00% 0/18 • Baseline through study completion (up to Day 14).	11.1% 2/18 • Number of events 2 • Baseline through study completion (up to Day 14).
General disorders Feeling hot	0.00% 0/18 • Baseline through study completion (up to Day 14).	33.3% 6/18 • Number of events 6 • Baseline through study completion (up to Day 14).
General disorders Lethargy	0.00% 0/18 • Baseline through study completion (up to Day 14).	5.6% 1/18 • Number of events 1 • Baseline through study completion (up to Day 14).
General disorders Thirst	0.00% 0/18 • Baseline through study completion (up to Day 14).	11.1% 2/18 • Number of events 2 • Baseline through study completion (up to Day 14).
General disorders Vessel puncture site anaesthesia	0.00% 0/18 • Baseline through study completion (up to Day 14).	5.6% 1/18 • Number of events 1 • Baseline through study completion (up to Day 14).
General disorders Vessel puncture site swelling	0.00% 0/18 • Baseline through study completion (up to Day 14).	5.6% 1/18 • Number of events 1 • Baseline through study completion (up to Day 14).
Musculoskeletal and connective tissue disorders Back pain	5.6% 1/18 • Number of events 1 • Baseline through study completion (up to Day 14).	5.6% 1/18 • Number of events 1 • Baseline through study completion (up to Day 14).
Musculoskeletal and connective tissue disorders Pain in extremity	5.6% 1/18 • Number of events 1 • Baseline through study completion (up to Day 14).	0.00% 0/18 • Baseline through study completion (up to Day 14).
Nervous system disorders Dizziness	0.00% 0/18 • Baseline through study completion (up to Day 14).	27.8% 5/18 • Number of events 5 • Baseline through study completion (up to Day 14).
Nervous system disorders Dysgeusia	0.00% 0/18 • Baseline through study completion (up to Day 14).	5.6% 1/18 • Number of events 1 • Baseline through study completion (up to Day 14).
Nervous system disorders Head discomfort	0.00% 0/18 • Baseline through study completion (up to Day 14).	5.6% 1/18 • Number of events 1 • Baseline through study completion (up to Day 14).
Nervous system disorders Headache	16.7% 3/18 • Number of events 3 • Baseline through study completion (up to Day 14).	44.4% 8/18 • Number of events 9 • Baseline through study completion (up to Day 14).
Nervous system disorders Paraesthesia	0.00% 0/18 • Baseline through study completion (up to Day 14).	16.7% 3/18 • Number of events 3 • Baseline through study completion (up to Day 14).
Reproductive system and breast disorders Dysmenorrhoea	33.3% 1/3 • Number of events 1 • Baseline through study completion (up to Day 14).	33.3% 1/3 • Number of events 1 • Baseline through study completion (up to Day 14).
Respiratory, thoracic and mediastinal disorders Dry throat	5.6% 1/18 • Number of events 1 • Baseline through study completion (up to Day 14).	5.6% 1/18 • Number of events 1 • Baseline through study completion (up to Day 14).
Respiratory, thoracic and mediastinal disorders Nasal congestion	0.00% 0/18 • Baseline through study completion (up to Day 14).	5.6% 1/18 • Number of events 1 • Baseline through study completion (up to Day 14).
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	0.00% 0/18 • Baseline through study completion (up to Day 14).	11.1% 2/18 • Number of events 2 • Baseline through study completion (up to Day 14).
Respiratory, thoracic and mediastinal disorders Rhinorrhoea	0.00% 0/18 • Baseline through study completion (up to Day 14).	5.6% 1/18 • Number of events 1 • Baseline through study completion (up to Day 14).
Respiratory, thoracic and mediastinal disorders Throat irritation	0.00% 0/18 • Baseline through study completion (up to Day 14).	11.1% 2/18 • Number of events 2 • Baseline through study completion (up to Day 14).
Skin and subcutaneous tissue disorders Acne	5.6% 1/18 • Number of events 1 • Baseline through study completion (up to Day 14).	0.00% 0/18 • Baseline through study completion (up to Day 14).
Skin and subcutaneous tissue disorders Hyperhidrosis	0.00% 0/18 • Baseline through study completion (up to Day 14).	5.6% 1/18 • Number of events 1 • Baseline through study completion (up to Day 14).
Skin and subcutaneous tissue disorders Skin warm	0.00% 0/18 • Baseline through study completion (up to Day 14).	5.6% 1/18 • Number of events 1 • Baseline through study completion (up to Day 14).
Vascular disorders Hot flush	0.00% 0/18 • Baseline through study completion (up to Day 14).	11.1% 2/18 • Number of events 2 • Baseline through study completion (up to Day 14).