A Study of Single Dose of ABT-333 in Healthy Male Adults
Status and phase
Completed
Phase 1
Conditions
HCV Infections
Treatments
Drug: Placebo
Drug: ABT-333
Details and patient eligibility
About
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.
Enrollment
39 patients
Sex
Male
Ages
20 to 50 years old
Volunteers
Accepts Healthy Volunteers
Inclusion criteria
- Subject has provided written consent.
- Subject is in general good health.
Exclusion criteria
- See above for main selection criteria.
Trial design
Primary purpose
Treatment
Allocation
Randomized
Interventional model
Single Group Assignment
Masking
Double Blind
39 participants in 5 patient groups, including a placebo group
Group 1
Experimental group
Description:
Single dose of 400 mg
Treatment:
Drug: ABT-333
Group 2
Experimental group
Description:
Single dose of 800 mg after safety evolution of Group I
Treatment:
Drug: ABT-333
Group 3
Experimental group
Description:
Single dose of 1200 mg after safety evolution of Group 2
Treatment:
Drug: ABT-333
Group 4
Experimental group
Description:
Single dose of 1600 mg after safety evolution of Group 3
Treatment:
Drug: ABT-333
Group 5
Placebo Comparator group
Description:
Single dose of placebo
Treatment:
Drug: Placebo
Trial contacts and locations
1
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Data sourced from clinicaltrials.gov
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