An Open-label, Randomized, Crossover Study to Evaluate the Bioavailability of Two Candidate Tablet Formulations of ABT-450 With Reference to the Hard Gelatin Capsule Formulation
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Abbott
- Enrollment
- 40
- Locations
- 1
- Primary Endpoint
- Assessment of Pharmacokinetics of two ABT-450 tablet formulations plus ritonavir and the ABT-450 capsule formulation plus ritonavir. Each dosed at low ABT-450/ritonavir
Study Overview
Brief Summary
The objective of this study is to assess the relative bioavailability of two test tablet formulations of ABT-450 as compared to the ABT-450 hard gelatin capsule formulation as a reference.
Detailed Description
This is a two part study. Part 1 is a single dose, three period, complete crossover study in approximately 21 subjects. Part 2 is a single dose, two period, complete crossover study in approximately 20 subjects.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 55 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
A
Low dose ABT-450 capsule and ritonavir capsules (reference).
Intervention: ABT-450 (Drug)
A
Low dose ABT-450 capsule and ritonavir capsules (reference).
Intervention: ritonavir (Drug)
B
Low dose ABT-450 SDD Tablet Form 1 and ritonavir capsules (test 1)
Intervention: ABT-450 (Drug)
B
Low dose ABT-450 SDD Tablet Form 1 and ritonavir capsules (test 1)
Intervention: ritonavir (Drug)
C
Low dose ABT-450 SDD Tablet Form 2 and ritonavir capsules (test 2).
Intervention: ABT-450 (Drug)
C
Low dose ABT-450 SDD Tablet Form 2 and ritonavir capsules (test 2).
Intervention: ritonavir (Drug)
D
High dose ABT-450 capsule and ritonavir capsules (reference).
Intervention: ritonavir (Drug)
D
High dose ABT-450 capsule and ritonavir capsules (reference).
Intervention: ABT-450 (Drug)
E
High dose ABT-450 SDD Tablet Form 1 or 2 and ritonavir capsule (test)
Intervention: ritonavir (Drug)
E
High dose ABT-450 SDD Tablet Form 1 or 2 and ritonavir capsule (test)
Intervention: ABT-450 (Drug)
Outcomes
Primary Outcomes
Assessment of Pharmacokinetics of two ABT-450 tablet formulations plus ritonavir and the ABT-450 capsule formulation plus ritonavir. Each dosed at low ABT-450/ritonavir
Time Frame: 72 hrs post dose
Assessment of Pharmacokinetics of the selected ABT-450 tablet formulations plus ritonavir and the ABT-450 capsule formulation plus ritonavir. Each dosed at high ABT-450/ritonavir
Time Frame: 72 hrs post dose
Secondary Outcomes
- To tabulate treatment emergent adverse events of two ABT-450 tablet formulations plus ritonavir and the ABT-450 capsule formulation plus ritonavir(Through 30 days post last dose.)