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

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01091649

Enrollment

Registered

2010-03-24

Start date

2010-02-28

Completion date

2010-04-30

Last updated

2010-12-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

Keywords

Pharmacokinetics, Safety

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.

Interventions

DRUGABT-450

Low dose ABT-450 / ritonavir see Arm Description for more information

DRUGritonavir

ritonavir see Arm Description for more information

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 55 Years

Healthy volunteers

Yes

Inclusion criteria

* Overall healthy subjects * Non-childbearing potential females included

Exclusion criteria

* Positive test for HAV IgM, HBsAg, anti-HCV Ab or anti-HIV Ab * Clinically significant cardiovascular, respiratory (except mild asthma), renal, gastrointestinal, hematologic, neurologic, thyroid, or any uncontrolled medical illness or psychiatric disorder * Use of tobacco or nicotine-containing products with the 6-month period prior to study drug administration * Abnormal screening laboratory results that are considered clinically significant by the investigator * Pregnant or breastfeeding female; requirement for any OTC and/or prescription medication, vitamins and/or herbal supplements on a regular basis * Previous exposure to ABT-450

Design outcomes

Primary

Measure	Time frame
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
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

Secondary

Measure	Time frame
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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026