Study in Healthy Adults to Evaluate Effect of Food on Pharmacokinetics, Safety and Tolerability of ABT-450 With Ritonavir

Randomized, Open-label, 2-period Cross-over Study in Healthy Adults to Evaluate the Effect of Food on Pharmacokinetics, Safety and Tolerability of ABT-450 With Ritonavir

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00909311

Enrollment

Registered

2009-05-28

Start date

2009-05-31

Completion date

Unknown

Last updated

2010-10-13

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

Conditions

HCV Infection

Keywords

Food effect

Brief summary

The purpose of this study is to evaluate the effect of food on pharmacokinetics, safety and tolerability of an experimental Hepatitis C Virus (HCV) protease inhibitor with ritonavir in healthy volunteers.

Detailed description

This is an open-label, randomized, 2 cross-over period fasting and non-fasting study.

Interventions

DRUGABT-450

capsules, QD, 1 dose in each cross-over period

DRUGritonavir

capsule, QD, 1 dose in each cross-over period

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

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

* history of significant sensitivity to any drug; * positive test for HAV IgM, HBsAg, anti-HCV Ab or anti-HIV Ab; * history of gastrointestinal issues or procedures; * history of seizures, diabetes or cancer (except basal cell carcinoma); * 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; * donation or loss of 550 mL or more blood volume or receipt of a transfusion of any blood product within 8 weeks prior to study drug administration; * abnormal screening laboratory results that are considered clinically significant by the investigator; * current enrollment in another clinical study; * previous enrollment in this study; * recent (6-month) history of drug/alcohol abuse that could preclude adherence to the protocol; * pregnant or breastfeeding female; * requirement for any OTC and/or prescription medication, vitamins and/or herbal supplements on a regular basis

Design outcomes

Primary

Measure	Time frame
Pharmacokinetics (blood draws, pre- and post-dose)	17 days
Safety and tolerability (ECGs, AEs, vitals, physical exams, routine labs)	30 days

Countries

United States

Outcome results

None listed

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