A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, Bioavailability, and Food-effects of EA1080 in Healthy Caucasian and Japanese Male Participants
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Healthy Volunteers
- Type
- Interventional
- Phase
- Phase 1
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentMasking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)Primary Purpose: Other
Participation Requirements
- Age
- Between 18 years and 45 years
- Gender
- Only males
Description
The drug being tested in this study is called EA1080. EA1080 is being tested to find a safe and well-tolerated dose in healthy Caucasian and Japanese male participants. The study consists of 4 parts as mentioned below: Part 1: Single ascending dose Formulation A: Part 1A: In healthy adult Caucasian ...
The drug being tested in this study is called EA1080. EA1080 is being tested to find a safe and well-tolerated dose in healthy Caucasian and Japanese male participants. The study consists of 4 parts as mentioned below: Part 1: Single ascending dose Formulation A: Part 1A: In healthy adult Caucasian male participants Part 1B: In healthy adult Japanese male participants Part 2: Bioavailability (BA) and Food Effect (FE): Part 2A: Four-way cross-over single dose (SD) in healthy adult Caucasian male participants for Formulation A and B Part 2B: Two-way cross-over SD in healthy adult Japanese male participants for FE for selected formulation chosen from Part 2A Part 3: SAD of the chosen formulation: Part 3A: In healthy adult Caucasian male participants for selected formulation chosen from Part 2A Part 3B: In healthy adult Japanese male participants for selected formulation chosen from Part 2A Part 3C: SD of Formulation C in healthy adult Caucasian male participants Part 4: Multiple ascending dose (MAD) of the chosen formulation: Part 4A: In healthy adult Caucasian male participants for selected formulation chosen from Part 2A Part 4B: In healthy adult Japanese male participants for selected formulation chosen from Part 2A
Tracking Information
- NCT #
- NCT04223960
- Collaborators
- Not Provided
- Investigators
- Not Provided
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