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

This study has been completed.
Sponsor:
Information provided by:
Abbott
ClinicalTrials.gov Identifier:
NCT01091649
First received: February 26, 2010
Last updated: December 17, 2010
Last verified: September 2010
  Purpose

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.


Condition Intervention Phase
Healthy
Drug: ABT-450
Drug: ritonavir
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Bio-availability Study
Intervention Model: Crossover Assignment
Masking: Open Label
Official 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

Resource links provided by NLM:


Further study details as provided by Abbott:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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. ] [ Designated as safety issue: Yes ]

Enrollment: 40
Study Start Date: February 2010
Study Completion Date: April 2010
Primary Completion Date: April 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: A
Low dose ABT-450 capsule and ritonavir capsules (reference).
Drug: ABT-450
Low dose ABT-450 / ritonavir see Arm Description for more information
Other Name: ABT-450
Drug: ritonavir
ritonavir see Arm Description for more information
Other Name: ABT-538, ritonavir, Norvir
Active Comparator: B
Low dose ABT-450 SDD Tablet Form 1 and ritonavir capsules (test 1)
Drug: ABT-450
Low dose ABT-450 / ritonavir see Arm Description for more information
Other Name: ABT-450
Drug: ritonavir
ritonavir see Arm Description for more information
Other Name: ABT-538, ritonavir, Norvir
Active Comparator: C
Low dose ABT-450 SDD Tablet Form 2 and ritonavir capsules (test 2).
Drug: ABT-450
Low dose ABT-450 / ritonavir see Arm Description for more information
Other Name: ABT-450
Drug: ritonavir
ritonavir see Arm Description for more information
Other Name: ABT-538, ritonavir, Norvir
Active Comparator: D
High dose ABT-450 capsule and ritonavir capsules (reference).
Drug: ritonavir
ritonavir see Arm Description for more information
Other Name: ABT-538, ritonavir, Norvir
Drug: ABT-450
High dose ABT-450 / ritonavir See Arm Description for more information
Other Name: ABT-450
Active Comparator: E
High dose ABT-450 SDD Tablet Form 1 or 2 and ritonavir capsule (test)
Drug: ritonavir
ritonavir see Arm Description for more information
Other Name: ABT-538, ritonavir, Norvir
Drug: ABT-450
High dose ABT-450 / ritonavir See Arm Description for more information
Other Name: ABT-450

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.

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01091649

Locations
United States, Illinois
Site Reference ID/Investigator# 27781
Waukegan, Illinois, United States, 60085
Sponsors and Collaborators
Abbott
Investigators
Study Director: Adebayo Lawal, M.D. Abbott
  More Information

No publications provided

Responsible Party: Adebayo Lawal, Global Project Director, Abbott
ClinicalTrials.gov Identifier: NCT01091649     History of Changes
Other Study ID Numbers: M10-797
Study First Received: February 26, 2010
Last Updated: December 17, 2010
Health Authority: United States: Food and Drug Administration

Keywords provided by Abbott:
Pharmacokinetics, Safety

Additional relevant MeSH terms:
Ritonavir
HIV Protease Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on April 20, 2014