Comparative Pharmacokinetics of LY3209590
Research type
Research Study
Full title
Comparative Pharmacokinetics of LY3209590 after Administration of a Lyophilized Formulation and a Solution Formulation in Healthy Participants
IRAS ID
288044
Contact name
Samuel Israel
Contact email
Sponsor organisation
Eli Lilly & Company, Ltd.
Eudract number
2020-003738-19
Clinicaltrials.gov Identifier
Clinicaltrials.gov Identifier
REC Ref, 20/NE/0204
Duration of Study in the UK
0 years, 9 months, 2 days
Research summary
This is a single-centre, double-blind, randomized, 2-period, 2-sequence crossover study in healthy participants. Total study duration is up to approximately 158 days.
• Screening Period: up to 28 days prior to the first dose.
• Treatment Periods: each period will consist of an 8-day residential period (Day -1 to Day 7) followed by outpatient visits on Days 15, 29, and 43. Participants will be administered a single subcutaneous (SC) dose of 10 mg LY3209590 on Day 1 in each period, with each dose separated by a washout (a period with no drug) of at least 65 days. Participants will also be administered a single SC dose of placebo on Day 1 in each period, to serve as a control for the assessment of injection-site reactions.
• Follow-up Visit: approximately 65 days after the final dose.Participants will be randomized 1:1 to the following treatment sequences:
Sequence Period 1 Period 2
1 Lyophilized Formulation Solution Formulation
2 Solution Formulation Lyophilized FormulationBlood sampling and safety assessments will be performed at defined time points during treatment through follow-up.
Approximately 50 participants will be enrolled such that 40 evaluable participants (20 in each treatment sequence) complete the study.
REC name
North East - York Research Ethics Committee
REC reference
20/NE/0204
Date of REC Opinion
7 Jan 2021
REC opinion
Further Information Favourable Opinion