A Study to Determine the Effect of Multiple Doses of BMS-955176 on the Electrocardiograph of Healthy Subjects

NCT02576119 | Terminated Phase 1 FDA Drug

• 2 other identifiers: 206220AI468-044
• Study Type: interventional
• Target: 315
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of the study is to determine the effect of multiple doses of BMS-955176 on the QT interval corrected with Fridericia's method (QTcF) in healthy subjects.

Conditions

Infection, Human Immunodeficiency Virus

Outcome Measures

Primary Outcomes (5)

• Part 1: Reported adverse events

  Selected time points up to 24 hours postdose

• Part 1: Vital sign measurements

  Selected time points up to 24 hours postdose

• Part 1: Physical examinations

  Selected time points up to 24 hours postdose

• Part 1: Safety 12-lead ECGs

  Selected time points up to 24 hours postdose

• Part 2: ΔΔQTcF, the subject specific time-matched difference between the ΔQTcF (QT interval corrected with Fridericia's method) after administration of BMS-955176 and the ΔQTcF after administration of placebo

  Days 1 to 28

Study Arms (2)

Part 1: Sentinal Cohorts

EXPERIMENTAL

Study is in 2 sequential cohorts (BMS-955176 or placebo) each to evaluate the safety, tolerability, and PK following multiple-dose administration of BMS-955176.

Drug: BMS-955176, Placebo (Part 1)

Part 2: Main QTc Study

EXPERIMENTAL

3 period nested crossover study.

Drug: BMS-955176, Moxifloxacin, Placebo (Part 2)

Interventions

BMS-955176, Placebo (Part 1) DRUG

The BMS-955176 dose in sentinel Cohort 1 will be 240 mg orally. The BMS-955176 dose in sentinel Cohort 2 will be determined based on the results of data from sentinel Cohort 1.

Part 1: Sentinal Cohorts

BMS-955176, Moxifloxacin, Placebo (Part 2) DRUG

Subjects will be randomized to 1 of 12 sequences. Each sequence includes combination of different regimens (combination of BMS-955176, placebo and Moxifloxacin).

Part 2: Main QTc Study

Eligibility Criteria

• Age: 18 Years - 49 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Written Informed Consent
• Healthy subjects as determined by no clinically significant deviation from normal in medical history, physical examination findings, 12-lead ECG measurements, physical measurements, and clinical laboratory test results
• Body mass index (BMI) of 18.0 kg/m2 to 32.0 kg/m2, inclusive, at screening and Day 1. BMI = weight (kg)/\[height(m)\]2
• Women must have a negative serum pregnancy test, must not be breastfeeding, and women of child bearing potential (WOCBP) must agree to follow instructions for method(s) of contraception for the duration of treatment with BMS-955176 in addition to a post-treatment completion period
• Males who are sexually active with WOCBP must agree to follow instructions for method(s) of contraception for the duration of treatment with BMS-955176 in addition to a post-treatment completion period

You may not qualify if:

• Any significant acute or chronic medical illness
• Any GI disease or surgery that can affect absorption of the study drug
• A personal history of clinically relevant cardiac disease, long QT syndrome, symptomatic or asymptomatic arrhythmias, presyncope or syncopal episodes, or additional risk factors for torsades de pointes (eg, heart failure)
• Evidence of organ dysfunction or any clinically significant deviation from normal in physical examination, vital signs, ECG or clinical laboratory determinations beyond what is consistent with the target population
• History of allergy to moxifloxacin, HIV maturation inhibitors, or related compounds

Sponsors & Collaborators

• ViiV Healthcare: lead
• GlaxoSmithKline: collaborator

Study Sites (1)

GSK Investigational Site

Austin, Texas, 78744, United States

Location

MeSH Terms

Conditions

Infections; Acquired Immunodeficiency Syndrome

Interventions

BMS-955176; Moxifloxacin

Condition Hierarchy (Ancestors)

HIV Infections; Blood-Borne Infections; Communicable Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Intervention Hierarchy (Ancestors)

Fluoroquinolones; 4-Quinolones; Quinolones; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• GSK Clinical Trials

  ViiV Healthcare

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 13, 2015
• First Posted: October 15, 2015
• Study Start: October 19, 2015
• Primary Completion: February 26, 2016
• Study Completion: October 14, 2016
• Last Updated: August 9, 2017

Record last verified: 2017-08

Locations

US (1)