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Bioavailability of BMS-626529 in Healthy Subjects From Prototype Low Dose Extended Release Formulations (Part 1) and Prototype Extended Release Multi-particulate Formulations (Part 2) of BMS-663068 Relative to 600 mg Extended Release Tablet

Primary Purpose

Infection, Human Immunodeficiency Virus

Status

Completed

Phase

Phase 1

Locations

United Kingdom

Study Type

Interventional

Intervention

BMS-663068

About this trial

This is an interventional health services research trial for Infection, Human Immunodeficiency Virus

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesAccepts Healthy Volunteers

For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com

Inclusion Criteria:

Males and females, 18 to 50 years of age, inclusive
Healthy subjects as determined by no clinically significant deviation from normal in medical and surgical history, PE findings, vital sign measurements, 12-lead ECG measurements, physical measurements, and clinical laboratory test results
Women of childbearing potential (WOCBP) must have a negative urine pregnancy test (performed for all females; minimum sensitivity 25 IU/L or equivalent units of human chorionic gonadotropin) within 24 hours prior to the start of study drug

Exclusion Criteria:

Any significant acute or chronic medical illness
Evidence of organ dysfunction or any clinically significant deviation from normal in PE, vital signs, ECG, or clinical laboratory determinations beyond what is consistent with the target population
Any of the following on 12-lead ECG prior to study drug administration, confirmed by repeat:
i) PR ≥ 210 msec ii) QRS ≥ 120 msec iii) QT ≥ 500 msec and iv) QTcF ≥ 450 msec
Exposure to any investigational drug or placebo within 12 weeks of study drug administration
Positive blood screen for hepatitis C antibody (HCV Ab), hepatitis B surface antigen (HBsAg), or HIV-1 and HIV-2 antibody

Sites / Locations

GSK Investigational Site

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm 8

Arm 9

Arm 10

Arm 11

Arm Type

Experimental

Arm Label

Part 1

Part 1: Prototype 1

Part 1: Prototype 2

Part 1: Prototype 3

Part 1: Prototype 4

Part 1: Prototype 5

Part 2

Part 2: Prototype 1

Part 2: Prototype 2

Part 2: Prototype 3

Part 2: Prototype 4

Arm Description

BMS-663068 1 × 600 mg extended-release (ER) tablet formulation

BMS-663068 600 mg ER low-dose tablet formulation (Prototype 1)

BMS-663068 600 mg ER low-dose tablet formulation (Prototype 2)

BMS-663068 600 mg ER low-dose tablet formulation (Prototype 3)

BMS-663068 600 mg ER low-dose tablet formulation (Prototype 4)

BMS-663068 600 mg ER low-dose tablet formulation (Prototype 5)

BMS-663068 1 × 600 mg ER tablet formulation

BMS-663068 600 mg ER prototype multi-particulate formulation (Prototype 1)

BMS-663068 600 mg ER prototype multi-particulate formulation (Prototype 2)

BMS-663068 600 mg ER prototype multi-particulate formulation (Prototype 3)

BMS-663068 600 mg ER prototype multi-particulate formulation (Prototype 4)

Outcomes

Primary Outcome Measures

Maximum observed concentration (Cmax) of BMS-626529

Area under the concentration-time curve from time zero to the time of the last quantifiable concentration (AUC(0-T)) of BMS-626529

Area under the concentration-time curve from time zero extrapolated to infinite time (AUC(INF)) of BMS-626529

Secondary Outcome Measures

Safety of BMS-663068 will be measured by incidence of Adverse events (AEs), Serious adverse events (SAEs), and AEs leading to discontinuation;, and results of clinical laboratory tests, vital signs, 12-lead ECGs, and Physical examination (PE)

Tolerability of BMS-663068 will be measured by incidence of AEs, SAEs, and AEs leading to discontinuation; and results of clinical laboratory tests, vital signs and 12-lead ECGs

Full Information

NCT ID

NCT02508064

First Posted

July 22, 2015

Last Updated

September 7, 2017

Sponsor

ViiV Healthcare

Collaborators

GlaxoSmithKline

1. Study Identification

Unique Protocol Identification Number

NCT02508064

Brief Title

Bioavailability of BMS-626529 in Healthy Subjects From Prototype Low Dose Extended Release Formulations (Part 1) and Prototype Extended Release Multi-particulate Formulations (Part 2) of BMS-663068 Relative to 600 mg Extended Release Tablet

Official Title

A Two-Part Study to Evaluate the Bioavailability of BMS-626529 Administered as Prodrug BMS-663068 From Prototype Low-Dose Extended-Release Tablets (Part 1) and Prototype Multi-Particulate Formulations (Part 2) Relative to the 600 mg Extended Release Tablet in Healthy Subjects

Study Type

Interventional

2. Study Status

Record Verification Date

September 2017

Overall Recruitment Status

Completed

Study Start Date

August 3, 2015 (Actual)

Primary Completion Date

November 5, 2015 (Actual)

Study Completion Date

November 5, 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

ViiV Healthcare

Collaborators

GlaxoSmithKline

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

This 2-part study will determine the bioavailability of BMS-626529 in healthy subjects from prototype low dose extended release formulations (Part 1) of BMS-663068 and prototype extended release multi-particulate formulations (Part 2) of BMS-663068 relative to 600 mg extended release tablet of BMS-663068.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Infection, Human Immunodeficiency Virus

7. Study Design

Primary Purpose

Health Services Research

Study Phase

Phase 1

Interventional Study Model

Crossover Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

27 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Part 1

Arm Type

Experimental

Arm Description

BMS-663068 1 × 600 mg extended-release (ER) tablet formulation

Arm Title

Part 1: Prototype 1

Arm Type

Experimental

Arm Description

BMS-663068 600 mg ER low-dose tablet formulation (Prototype 1)

Arm Title

Part 1: Prototype 2

Arm Type

Experimental

Arm Description

BMS-663068 600 mg ER low-dose tablet formulation (Prototype 2)

Arm Title

Part 1: Prototype 3

Arm Type

Experimental

Arm Description

BMS-663068 600 mg ER low-dose tablet formulation (Prototype 3)

Arm Title

Part 1: Prototype 4

Arm Type

Experimental

Arm Description

BMS-663068 600 mg ER low-dose tablet formulation (Prototype 4)

Arm Title

Part 1: Prototype 5

Arm Type

Experimental

Arm Description

BMS-663068 600 mg ER low-dose tablet formulation (Prototype 5)

Arm Title

Part 2

Arm Type

Experimental

Arm Description

BMS-663068 1 × 600 mg ER tablet formulation

Arm Title

Part 2: Prototype 1

Arm Type

Experimental

Arm Description

BMS-663068 600 mg ER prototype multi-particulate formulation (Prototype 1)

Arm Title

Part 2: Prototype 2

Arm Type

Experimental

Arm Description

BMS-663068 600 mg ER prototype multi-particulate formulation (Prototype 2)

Arm Title

Part 2: Prototype 3

Arm Type

Experimental

Arm Description

BMS-663068 600 mg ER prototype multi-particulate formulation (Prototype 3)

Arm Title

Part 2: Prototype 4

Arm Type

Experimental

Arm Description

BMS-663068 600 mg ER prototype multi-particulate formulation (Prototype 4)

Intervention Type

Drug

Intervention Name(s)

BMS-663068

Intervention Description

BMS-663068

Primary Outcome Measure Information:

Title

Maximum observed concentration (Cmax) of BMS-626529

Time Frame

Day 1 to Day 4 of each period

Title

Area under the concentration-time curve from time zero to the time of the last quantifiable concentration (AUC(0-T)) of BMS-626529

Time Frame

Day 1 to Day 4 of each period

Title

Area under the concentration-time curve from time zero extrapolated to infinite time (AUC(INF)) of BMS-626529

Time Frame

Day 1 to Day 4 of each period

Secondary Outcome Measure Information:

Title

Time Frame

Day 1 to Day 4 of each period; for SAEs up to 30 days post discontinuation of dosing

Title

Tolerability of BMS-663068 will be measured by incidence of AEs, SAEs, and AEs leading to discontinuation; and results of clinical laboratory tests, vital signs and 12-lead ECGs

Time Frame

Day 1 to Day 4 of each period; for SAEs up to 30 days post discontinuation of dosing

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

50 Years

Accepts Healthy Volunteers

Eligibility Criteria

For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com Inclusion Criteria: Males and females, 18 to 50 years of age, inclusive Healthy subjects as determined by no clinically significant deviation from normal in medical and surgical history, PE findings, vital sign measurements, 12-lead ECG measurements, physical measurements, and clinical laboratory test results Women of childbearing potential (WOCBP) must have a negative urine pregnancy test (performed for all females; minimum sensitivity 25 IU/L or equivalent units of human chorionic gonadotropin) within 24 hours prior to the start of study drug Exclusion Criteria: Any significant acute or chronic medical illness Evidence of organ dysfunction or any clinically significant deviation from normal in PE, vital signs, ECG, or clinical laboratory determinations beyond what is consistent with the target population Any of the following on 12-lead ECG prior to study drug administration, confirmed by repeat: i) PR ≥ 210 msec ii) QRS ≥ 120 msec iii) QT ≥ 500 msec and iv) QTcF ≥ 450 msec Exposure to any investigational drug or placebo within 12 weeks of study drug administration Positive blood screen for hepatitis C antibody (HCV Ab), hepatitis B surface antigen (HBsAg), or HIV-1 and HIV-2 antibody

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

GSK Clinical Trials

Organizational Affiliation

ViiV Healthcare

Official's Role

Study Director

Facility Information:

Facility Name

GSK Investigational Site

City

Nottingham

ZIP/Postal Code

NG11 6JS

Country

United Kingdom

12. IPD Sharing Statement

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