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A Study of the Relative Bioavailability of BMS-626529 Administered as BMS-663068 From 150mg Low-dose Extended-release Tablets Compared to 600mg Reference Extended-release Tablets in Healthy Subjects

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02859259
Recruitment Status : Completed
First Posted : August 9, 2016
Last Update Posted : May 15, 2017
Sponsor:
Information provided by (Responsible Party):
ViiV Healthcare

Brief Summary:
An oral dose in healthy subjects to determine the relative bioavailabilty of BMS-626529 administered as BMS-663068

Condition or disease Intervention/treatment Phase
Infection, Human Immunodeficiency Virus Drug: BMS-663068 (1 tablet at 600 mg) Drug: BMS-663068 (4 tablets at 150 mg each tablet) Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 14 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Relative Bioavailability Study of BMS-626529 Administered as Prodrug BMS-663068 From 150-mg Low-dose Extended-release Tablets Compared to 600-mg Reference Extended-release Tablet in Healthy Subjects
Actual Study Start Date : August 12, 2016
Actual Primary Completion Date : August 12, 2016
Actual Study Completion Date : August 12, 2016

Arm Intervention/treatment
Experimental: Treatment A: reference extended-release (ER) 1 tablet at 600mg
A single dose of BMS-663068 administered orally as specified
Drug: BMS-663068 (1 tablet at 600 mg)
BMS-663068 (1 tablet at 600 mg). A single dose of BMS-663068 administered orally as specified.

Experimental: Treatment B: low-dose ER 4 tablets at 150mg
A single dose (4 tablets) of BMS-663068 administered orally as specified
Drug: BMS-663068 (4 tablets at 150 mg each tablet)
BMS-663068 (4 tablets at 150 mg each tablet). A single dose (4 tablets) of BMS-663068 administered orally as specified.




Primary Outcome Measures :
  1. Bioavailability of BMS-626529 from low-dose ER tablet formulation of BMS-663068 relative to the reference ER tablet formulation. [ Time Frame: Approximately 8 days ]

Secondary Outcome Measures :
  1. Safety and Tolerability as assessed by the Incidence of Serious Adverse Events (SAEs), Adverse Events (AEs), AEs leading to discontinuation, and the results of electrocardiogram tests (ECGs), vital signs, physical exams, and clinical laboratory tests. [ Time Frame: Approximately 8 days ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Signed Informed Consent
  2. Target Population: Healthy subjects as determined by no clinically significant deviation from normal in medical and surgical history, physical examination, vital sign measurements, 12-lead ECG measurements and clinical laboratory test results. Body mass index (BMI) of 18.0 to 32.0 kg/m².
  3. Subject Re-enrollment: This study permits the re-enrollment of a subject that has discontinued the study as a pre-treatment failure (i.e., subject has not been randomized/ has not been treated). If re-enrolled, the subject must be re-consented.
  4. Age: Males and Females, ages 18 or age of majority to 50 years, inclusive.
  5. Reproductive Status: Women of childbearing potential (WOCBP) must have a negative serum/urine (urine test not allowed at screening and Day -1 of Period 1) pregnancy test (minimum sensitivity 25 IU/L or equivalent units of human chorionic gonadotropin) within 24 hours prior to the start of study drug. Women must not be breastfeeding. Women of childbearing potential must agree to follow instructions for method(s) of contraception for the duration of treatment with study drug plus 5 half-lives of study drug (60 hours) plus 30 days (duration of ovulatory cycle) for a total of 33 days post-treatment completion. Males who are sexually active with WOCBP must agree to follow instructions for method(s) of contraception for the duration of treatment with study drug plus 5 half-lives of study drug (60 hours). In addition, male subjects must be willing to refrain from sperm donation during this time. Azoospermic males are exempt from contraceptive requirements. Women of childbearing potential who are continuously not heterosexually active are also exempt from contraceptive requirements, and still undergo pregnancy testing as described in this section.

Exclusion Criteria:

  1. Medical History and Concurrent Diseases: History of any chronic or acute illness, gastrointestinal disease, gastrointestinal surgery within less than 4 weeks of dosing, blood donation within 4 weeks of dosing, blood transfusion within 4 weeks of dosing, smoking within less than 12 months prior to dosing, alcohol abuse, inability to tolerate oral medication, or inability to be venipunctured. Any other sound medical, psychiatric and/or social reason as determined by the investigator.
  2. Physical and Laboratory Test Findings: Evidence of organ dysfunction or any clinically significant deviation from normal in physical examination, vital signs measurements, ECGs, or clinical laboratory determinations beyond what is consistent with the target population.
  3. Exposure to any investigational drug or placebo within 4 weeks of study drug administration.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02859259


Locations
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United States, Texas
GSK Investigational Site
Dallas, Texas, United States, 75247
Sponsors and Collaborators
ViiV Healthcare
Investigators
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Study Director: GSK Clinical Trials ViiV Healthcare
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Responsible Party: ViiV Healthcare
ClinicalTrials.gov Identifier: NCT02859259    
Other Study ID Numbers: 206219
AI438-080 ( Other Identifier: Bristol-Myers Squibb )
First Posted: August 9, 2016    Key Record Dates
Last Update Posted: May 15, 2017
Last Verified: May 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Acquired Immunodeficiency Syndrome
HIV Infections
Immunologic Deficiency Syndromes
Immune System Diseases
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Slow Virus Diseases