Study in Healthy Adults to Evaluate the Bioavailability of Two Test Tablet Formulations of ABT-450

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: ABT-450; Drug: ritonavir

• Registration Number: NCT01091649
• Lead Sponsor: Abbott

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 Timeline

• Study Start: 2010-02
• Study First Submitted: 2010-02-26
• Study First Submitted QC: 2010-03-22
• Study First Posted: 2010-03-24
• Primary Completion: 2010-04
• Study Completion: 2010-04
• Status Verified: 2010-09
• Last Update Submitted: 2010-12-17
• Last Update Posted: 2010-12-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
A	ABT-450	Low dose ABT-450 capsule and ritonavir capsules (reference).
B	ABT-450	Low dose ABT-450 SDD Tablet Form 1 and ritonavir capsules (test 1)
C	ABT-450	Low dose ABT-450 SDD Tablet Form 2 and ritonavir capsules (test 2).
E	ABT-450	High dose ABT-450 SDD Tablet Form 1 or 2 and ritonavir capsule (test)
D	ABT-450	High dose ABT-450 capsule and ritonavir capsules (reference).
B	ritonavir	Low dose ABT-450 SDD Tablet Form 1 and ritonavir capsules (test 1)
A	ritonavir	Low dose ABT-450 capsule and ritonavir capsules (reference).
C	ritonavir	Low dose ABT-450 SDD Tablet Form 2 and ritonavir capsules (test 2).
D	ritonavir	High dose ABT-450 capsule and ritonavir capsules (reference).
E	ritonavir	High dose ABT-450 SDD Tablet Form 1 or 2 and ritonavir capsule (test)

Primary Outcome Measures

Name	Time	Method
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	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	72 hrs post dose

Secondary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Site Reference ID/Investigator# 27781; 🇺🇸 Waukegan, Illinois, United States