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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 September 18, 2014