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Completed

NCT Number: NCT01091649

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

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.

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Key information

Conditions

Healthy

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Site Reference ID/Investigator# 27781

Waukegan, Illinois, 60085, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ABT-450

Drug

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

Ritonavir

Drug

ritonavir see Arm Description for more information

Other names: ABT-538, ritonavir, Norvir

Primary outcomes

  1. 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

  2. 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

  1. To tabulate treatment emergent adverse events of two ABT-450 tablet formulations plus ritonavir and the ABT-450 capsule formulation plus ritonavir

    Time frame: Through 30 days post last dose.

Sponsors and collaborators

Lead sponsor

Abbott

Industry

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2010
Study completion
2010
First posted
Mar 24, 2010
Registry last updated
Dec 21, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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