Trial Outcomes & Findings for A Study to Measure Baricitinib (LY3009104) Absorption in Healthy Participants (NCT NCT02340104)

NCT ID: NCT02340104

Last Updated: 2017-06-01

Results Overview

AUC\[0-∞\] is is the area under the concentration verses time curve from zero to infinity, reported as nanograms times hour per milliliter (ng\*h/mL).

• Recruitment status: COMPLETED
• Study phase: PHASE1
• Target enrollment: 8 participants
• Primary outcome timeframe: Predose, 0.5, 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 4, 6, 8, 12, 16, 24, 36, 48 and 72 Hours Postdose
• Results posted on: 2017-06-01

Participant Flow

Participant milestones

Measure	Baricitinib Single oral dose of 4 mg baricitinib on Day 1 and approximately the same time a single intravenous (IV) infusion of 4 µg \[\^13C4D3\^15N\]-baricitinib over 1.5 hours.
Overall Study STARTED	8
Overall Study COMPLETED	8
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

A Study to Measure Baricitinib (LY3009104) Absorption in Healthy Participants

Baseline characteristics by cohort

Measure	All Participants n=8 Participants Single oral dose of 4 mg baricitinib on Day 1 and at the same time a single intravenous (IV) infusion of 4 µg \[\^13C4D3\^15N\]-baricitinib over 1.5 hours.
Age, Continuous	42.8 years STANDARD_DEVIATION 17.2 • n=93 Participants
Sex: Female, Male Female	1 Participants n=93 Participants
Sex: Female, Male Male	7 Participants n=93 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=93 Participants
Race (NIH/OMB) Asian	0 Participants n=93 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=93 Participants
Race (NIH/OMB) Black or African American	0 Participants n=93 Participants
Race (NIH/OMB) White	8 Participants n=93 Participants
Race (NIH/OMB) More than one race	0 Participants n=93 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=93 Participants
Region of Enrollment United Kingdom	8 Participants n=93 Participants

PRIMARY outcome

Timeframe: Predose, 0.5, 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 4, 6, 8, 12, 16, 24, 36, 48 and 72 Hours Postdose

Population: All participants who received at least 1 dose of study drug.

AUC[0-∞] is is the area under the concentration verses time curve from zero to infinity, reported as nanograms times hour per milliliter (ng*h/mL).

Outcome measures

Measure	Baricitinib Oral Dose n=8 Participants Single oral dose of 4 mg baricitinib	[^13C4D3^15N]-Baricitinib IV n=8 Participants Single intravenous (IV) infusion of 4 µg\[\^13C4D3\^15N\]-baricitinib over 1.5 hours
Pharmacokinetics: Area Under the Concentration Versus Time Curve From Zero to Infinity (AUC[0-∞]) of Baricitinib Following Both the Oral and the IV Dose	216 ng*h/mL Geometric Coefficient of Variation 27	0.274 ng*h/mL Geometric Coefficient of Variation 29

Adverse Events

Baricitinib

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Baricitinib n=8 participants at risk Single oral dose of 4 mg baricitinib on Day 1 and at the same time a single intravenous (IV) infusion of 4 µg \[\^13C4D3\^15N\]-baricitinib over 1.5 hours
General disorders Fatigue	12.5% 1/8 • Number of events 1
Musculoskeletal and connective tissue disorders Back pain	12.5% 1/8 • Number of events 1
Nervous system disorders Headache	12.5% 1/8 • Number of events 1

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