Study of Dolutegravir (DTG) on PK of Cenicriviroc (CVC), and CVC on PK of DTG & on a Single Dose of Midazolam

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-03-31

Study Completion Date

2013-05-31

Brief Summary

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To evaluate the PK, safety and tolerability of Cenicriviroc (CVC) administered with and without Dolutegravir (DTG) and CVC with and without a single dose of Midazolam in healthy subjects.

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Detailed Description

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Primary Objectives

* To evaluate the steady-state PK of CVC administered with and without DTG .
* To evaluate the steady-state PK of DTG administered with and without CVC .
* To evaluate the PK of a single dose of Midazolam administered with and without steady state CVC when both are administered orally.

Secondary Objectives

* To evaluate the safety and tolerability of CVC administered with and without DTG.
* To evaluate the safety and tolerability of CVC administered with and without Midazolam.

Conditions

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HIV-infection/AIDS

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

CROSSOVER

Blinding Strategy

NONE

Study Groups

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Cenicriviroc + Midazolam, and CVC + DTG

Grp 1: CVC 150mg qd alone from Days 1-10; CVC 150mg qd + DTG 50mg qd from Days 11-20. A single dose of midazolam 5mg administered alone on Day -1 \& w/ CVC 150mg on Day 9.

Group Type EXPERIMENTAL

Cenicriviroc

Intervention Type DRUG

Dolutegravir

Intervention Type DRUG

Midazolam

Intervention Type DRUG

Dolutegravir , and DTG + CVC

Grp 2: DTG 50 mg qd alone from Days 1-10, DTG 50 mg qd + CVC 150 mg qd from Days 11-20.

Group Type EXPERIMENTAL

Cenicriviroc

Intervention Type DRUG

Dolutegravir

Intervention Type DRUG

Interventions

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Cenicriviroc

Intervention Type DRUG

Dolutegravir

Intervention Type DRUG

Midazolam

Intervention Type DRUG

Other Intervention Names

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CVC DTG Dormicum Hypnovel Versed

Eligibility Criteria

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Inclusion Criteria

1. Provide written informed voluntary consent
2. Adult male and female healthy volunteers
3. Body mass index (BMI) ≥ 18.0 and ≤ 30.0 kg/m2.
4. Be in good general health with no clinically relevant abnormalities
5. Agree to comply with study procedures and restrictions

Exclusion Criteria

1. Any disease or condition that might affect drug absorption, metabolism, or excretion, or clinically significant cardiovascular as determined by investigator
2. History of stomach or intestinal surgery, except for fully healed appendectomy and/or cholecystectomy which will be allowed
3. Clinically significant illness or clinically significant surgery within 4 weeks before the administration of study medication
4. Known or suspected hypersensitivity or allergic reaction to any of the components of CVC or DTG tablets, or midazolam syrup
5. Serum ALT, AST, or bilirubin values greater than or equal to Division of Acquired Immunodeficiency Syndrome (DAIDS) grade 1 at screening

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes