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

Sponsor
Abbott (Industry)
Overall Status
Completed
CT.gov ID
NCT01091649
Collaborator
(none)
40
Enrollment
1
Location
5
Arms
1.9
Duration (Months)
20.6
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
Phase 1

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
40 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
None (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
Study Start Date :
Feb 1, 2010
Actual Primary Completion Date :
Apr 1, 2010
Actual Study Completion Date :
Apr 1, 2010

Arms and Interventions

Arm Intervention/Treatment
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

Drug: ritonavir
ritonavir see Arm Description for more information
Other Names:
  • 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

    Drug: ritonavir
    ritonavir see Arm Description for more information
    Other Names:
  • 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

    Drug: ritonavir
    ritonavir see Arm Description for more information
    Other Names:
  • 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 Names:
  • ABT-538, ritonavir, Norvir

    • Drug: ABT-450
    High dose ABT-450 / ritonavir See Arm Description for more information
    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 Names:
  • ABT-538, ritonavir, Norvir

    • Drug: ABT-450
    High dose ABT-450 / ritonavir See Arm Description for more information

    Outcome Measures

    Primary Outcome Measures

    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 [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 [72 hrs post dose]

    Secondary Outcome Measures

    1. 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.]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 55 Years
    Sexes Eligible for Study:
    All
    Accepts 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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Site Reference ID/Investigator# 27781 Waukegan Illinois United States 60085

    Sponsors and Collaborators

    • Abbott

    Investigators

    • Study Director: Adebayo Lawal, M.D., Abbott

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT01091649
    Other Study ID Numbers:
    • M10-797
    First Posted:
    Mar 24, 2010
    Last Update Posted:
    Dec 21, 2010
    Last Verified:
    Sep 1, 2010
    Keywords provided by , ,
    Pharmacokinetics, Safety
    Additional relevant MeSH terms:
    Ritonavir

    Study Results

    No Results Posted as of Dec 21, 2010