A Double-blind, Randomized, Placebo-controlled Phase 1 Study in Healthy Male Adults to Evaluate the Safety, Tolerability and Pharmacokinetic Profiles of Single Dose of ABT-333
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Abbott
- Enrollment
- 39
- Locations
- 1
- Primary Endpoint
- To assess single dose safety and tolerability of an ABT-333 tablet formulation relative to placebo by the evaluation of vital signs, ECGs, physical exams, clinical lab testing and adverse event monitoring
Study Overview
Brief Summary
The objectives of this study is to assess the safety, tolerability, and pharmacokinetics of blind, escalating, single, oral doses of ABT-333 under nonfasting conditions in healthy male adult in Japan.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 20 Years to 50 Years (Adult)
- Sex
- Male
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Subject has provided written consent.
- •Subject is in general good health.
Exclusion Criteria
- •See above for main selection criteria.
Arms & Interventions
Group 1
Single dose of 400 mg
Intervention: ABT-333 (Drug)
Group 2
Single dose of 800 mg after safety evolution of Group I
Intervention: ABT-333 (Drug)
Group 3
Single dose of 1200 mg after safety evolution of Group 2
Intervention: ABT-333 (Drug)
Group 4
Single dose of 1600 mg after safety evolution of Group 3
Intervention: ABT-333 (Drug)
Group 5
Single dose of placebo
Intervention: Placebo (Drug)
Outcomes
Primary Outcomes
To assess single dose safety and tolerability of an ABT-333 tablet formulation relative to placebo by the evaluation of vital signs, ECGs, physical exams, clinical lab testing and adverse event monitoring
Time Frame: Daily assessment for 5 days then day 30 or more frequently as needed
To evaluate single dose pharmacokinetics of an ABT-333 tablet formulation
Time Frame: Day 1-3
Secondary Outcomes
No secondary outcomes reported