NCT02164812

Brief Summary

The purpose of this study is to determine whether multiple doses of Efavirenz has an effect on the QTc interval (corrected by Fridericia) in CYP2B6 \*1/\*6 and \*6/\*6 healthy subjects.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
58

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Jul 2014

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 13, 2014

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 17, 2014

Completed
14 days until next milestone

Study Start

First participant enrolled

July 1, 2014

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2015

Completed
Last Updated

September 7, 2015

Status Verified

September 1, 2015

Enrollment Period

1.1 years

First QC Date

June 13, 2014

Last Update Submit

September 3, 2015

Conditions

HIV/AIDS

Outcome Measures

Primary Outcomes (1)

  • Difference from placebo of Efavirenz (EFV) in change from period-specific baseline in the QT interval corrected for heart rate (HR) via Fridericia's method (QTcF) at postdose extraction times (ΔΔQTcF)

    QTcF = QT corrected for Fridericia's formula

    Days 1, 2, 5, 6, 19 and 20

Secondary Outcomes (8)

  • Difference from placebo of EFV in change from period-specific baseline in other ECG parameters: HR, PR, QRS, and uncorrected QT following 14 days of dosing

    Days 1, 5 and 19

  • Difference from placebo of Moxifloxacin in change from period-specific baseline in QTcF (ΔΔQTcF) following a single dose

    Days 1, 5 and 19

  • Number and percent of subjects having a maximum QTcF, HR, PR, and QRS outside of pre-specified categories and those having a maximum ΔQTcF outside of pre-specified categories

    Days 1, 5 and 19

  • Time of maximum observed plasma concentration (Tmax) of EFV

    Days 1, 2, 19 and 20

  • Maximum observed plasma concentration (Cmax) of EFV

    Days 1, 2, 19 and 20

  • +3 more secondary outcomes

Study Arms (1)

Moxifloxacin, Placebo, Efavirenz

EXPERIMENTAL

Moxifloxacin, Placebo, Efavirenz single dose as specified

Drug: MoxifloxacinDrug: PlaceboDrug: Efavirenz

Interventions

MoxifloxacinDRUG
Also known as: Avelox®
Moxifloxacin, Placebo, Efavirenz
PlaceboDRUG
Moxifloxacin, Placebo, Efavirenz
EfavirenzDRUG
Also known as: Sustiva®, BMS-561525
Moxifloxacin, Placebo, Efavirenz

Eligibility Criteria

Age18 Years - 49 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy volunteers, ages 18 to 49 years old
  • BMI 18 to 32 kg/m2
  • Women must not be pregnant or breastfeeding

You may not qualify if:

  • A personal history of clinically relevant cardiac disease, symptomatic or asymptomatic arrhythmias, presyncope or syncopal episodes, or additional risk factors for torsades de pointes (eg, heart failure)
  • History of hypokalemia, personal history or family history of prolonged QT interval, or family history of sudden cardiac death at a young age
  • Any of the following on 12-lead electrocardiogram (ECG) prior to study drug administration: PR ≥210 msec, QRS ≥120 msec, QT ≥500 msec, QTcF ≥450 msec, HR \<45 bpm
  • Second or third degree heart block prior to study drug
  • Positive urine screen for drugs of abuse
  • Positive blood screen for hepatitis C antibody, hepatitis B surface antigen, or Human Immunodeficiency Virus (HIV)-1, -2 antibody
  • Any of the following lab results outside of the ranges specified below prior to dosing: Alanine aminotransferase (ALT) \>upper limit of normal (ULN), aspartate aminotransferase (AST) \>ULN, Total bilirubin \>ULN, Direct bilirubin \>ULN, Creatinine \>ULN, Serum potassium \<lower limit of normal (LLN), Serum magnesium \<LLN
  • History of allergy to Moxifloxacin, Efavirenz or related compounds

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Parexel International - Baltimore Epcu

Baltimore, Maryland, 21225, United States

Location

Related Publications (1)

  • Abdelhady AM, Shugg T, Thong N, Lu JB, Kreutz Y, Jaynes HA, Robarge JD, Tisdale JE, Desta Z, Overholser BR. Efavirenz Inhibits the Human Ether-A-Go-Go Related Current (hERG) and Induces QT Interval Prolongation in CYP2B6*6*6 Allele Carriers. J Cardiovasc Electrophysiol. 2016 Oct;27(10):1206-1213. doi: 10.1111/jce.13032. Epub 2016 Jul 25.

    PMID: 27333947DERIVED

Related Links

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome

Interventions

Moxifloxacinefavirenz

Condition Hierarchy (Ancestors)

HIV InfectionsBlood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesSlow Virus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System Diseases

Intervention Hierarchy (Ancestors)

Fluoroquinolones4-QuinolonesQuinolonesQuinolinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Officials

  • Bristol-Myers Squibb

    Bristol-Myers Squibb

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 13, 2014

First Posted

June 17, 2014

Study Start

July 1, 2014

Primary Completion

August 1, 2015

Study Completion

August 1, 2015

Last Updated

September 7, 2015

Record last verified: 2015-09

Locations

US(1)