A Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Antiretroviral Activity of MK-8507 in HIV-1 Infected Patients

Merck Sharp & Dohme LLC0 sites18 target enrollmentSeptember 15, 2014

ConditionsHIV-1 Infection

InterventionsUlonivirine

DrugsUlonivirine

Overview

Phase: Phase 1
Intervention: Ulonivirine
Conditions: HIV-1 Infection
Sponsor: Merck Sharp & Dohme LLC
Enrollment: 18
Primary Endpoint: Change from Baseline in Plasma HIV-1 RNA
Status: Completed
Last Updated: 3 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Similar Trials

Overview

Brief Summary

The study will evaluate the safety, tolerability, pharmacokinetics, and antiretroviral activity of a single dose of ulonivirine in antiretroviral therapy (ART)-naive, HIV-1 infected participants. The hypothesis tested in the study is that at a safe and well-tolerated dose, ulonivirine has superior antiretroviral activity to a historical placebo control, as measured by change from baseline in plasma HIV-1 ribonucleic acid (RNA) at 168 hours postdose.

Registry

clinicaltrials.gov

Start Date

September 15, 2014

End Date

July 23, 2015

Last Updated

3 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Merck Sharp & Dohme LLC

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Male, or non-pregnant and non-breastfeeding female, or postmenopausal or surgically sterile female (confirmed with medical records, examination, or laboratory test). Male participants with female partner of childbearing potential agrees to use a medically acceptable method of contraception during the study and 90 days after receiving study drug.
•Body mass index \<=35 kg/m\^2
•Other than HIV infection, baseline health judged to be stable at screening and/or prior to administration of study drug
•No clinically-significant electrocardiogram abnormality
•Documented to be HIV-1 positive as determined by a positive enzyme-linked immunosorbent assay (ELISA) or quantitative polymerase chain reaction (PCR) result with confirmation
•Has a screening plasma Cluster of Differentiation (CD4) T-cell count of \>200 /mm\^3
•Has a plasma HIV-1 RNA \>= 10,000 copies/mL within 30 days before administration of study drug
•ART-naive, defined as never having received any ART agent, or have received \<=30 consecutive days of an investigational ART agent, excluding non-nucleoside reverse transcriptase inhibitors (NNRTIs), or have received \<=60 consecutive days of combination ART, excluding NNRTIs
•Has not received an investigational agent or licensed ART within 30 days of study drug administration
•Diagnosed with HIV-1 infection \>=3 months before screening

Exclusion Criteria

•Mentally or legally institutionalized or incapacitated, has significant emotional problems, or has a history of clinically significant psychiatric disorder
•History of clinically significant and not stably controlled abnormalities or diseases
•History of cancer, with the exceptions of 1) adequately-treated non-melanomatous skin carcinoma or carcinoma in situ of the cervix, 2) other malignancies which have been successfully treated \>=10 years before screening, or 3) participants who are highly unlikely to sustain a recurrence for the duration of the study
•History of significant multiple and/or severe allergies, or has had an anaphylactic reaction or significant intolerability to drugs or food
•Positive for hepatitis B surface antigen
•History of chronic hepatitis C virus (HCV) unless there has been a documented cure or a negative HCV viral load
•Had major surgery, or donated or lost \>=1 unit (\~500 mL) of blood within 4 weeks before screening
•Participated in another investigational trial within 4 weeks before administration of study drug
•Unable to refrain from or anticipates the use of any medication beginning 4 weeks before administration of study drug and throughout the trial. Certain medications are permitted.
•Consumes \>3 glasses of alcoholic beverages per day (1 glass is equivalent to 12 ounces of beer, 4 ounces of wine, or 1 ounce of distilled spirits). Participants who consume 4 glasses of alcoholic beverages per day may be enrolled at the discretion of the investigator.

Arms & Interventions

Panel A: Ulonivirine 600 mg

Single oral dose of ulonivirine 600 mg (supplied as 10 mg and 100 mg tablets) administered after an overnight fast

Intervention: Ulonivirine

Panel B: Ulonivirine 150 mg

Single oral dose of ulonivirine 150 mg (supplied as 10 mg and 100 mg tablets) administered after an overnight fast

Intervention: Ulonivirine

Panel C: Ulonivirine <=600 mg

Single oral dose of ulonivirine \<=600 mg mg (supplied as 10 mg and 100 mg tablets) administered after an overnight fast. Inclusion of Panel C in the study, and the dose selected, will be decided pending evaluation of results for Panels A and B.

Intervention: Ulonivirine

Outcomes

Primary Outcomes

Change from Baseline in Plasma HIV-1 RNA

Time Frame: 168 hours (7 days) postdose

Number of Participants with One or More Adverse Experiences

Time Frame: Up to 21 days postdose

Secondary Outcomes

Plasma Concentration of Ulonivirine at 336 Hours Postdose (C336hr)(336 hours postdose)
Area Under the Plasma Concentration-Time Curve of Ulonivirine (AUC0-168hr)(Up to 168 hours postdose)
Maximum Plasma Concentration of Ulonivirine (Cmax)(Up to 336 hours postdose)
Time of Maximum Plasma Concentration of Ulonivirine (Tmax)(Up to 336 hours postdose)
Plasma Concentration of Ulonivirine at 168 Hours Postdose (C168hr)(168 hours postdose)
Apparent Terminal Half-Life (T1/2) of Plasma Ulonivirine(Up to 336 hours postdose)