Clinical trial NCT01827540: Study of Dolutegravir (DTG) on PK of Cenicriviroc (CVC), and CVC on PK of DTG & on a Single Dose of Midazolam
Official title: A Phase I, Multiple-Dose, Open-Label, Crossover Study in Healthy Subjects to Assess the Effect of Dolutegravir (DTG) on the Pharmacokinetics (PK) of Cenicriviroc (CVC) and the Effect of CVC on the PK of DTG and on a Single Dose of Midazolam
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: HIV-infection/AIDS
Keywords: HIV/AIDS
Cenicriviroc (CVC)
Dolutegravir (DTG)
Midazolam
Healthy Subjects
Lead sponsor: Tobira Therapeutics, Inc.
Sponsor class: INDUSTRY
Collaborators: name: ViiV Healthcare
First posted: 2013-04-09
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Pharmacokinetic Assessment of Cenicriviroc
timeFrame: 0 (predose), 0.5, 1, 2, 3, 4, 6, 8, 10, 12, & 24 hours postdose on Days 10 and 20
measure: Pharmacokinetic Assessment of Dolutegravir
timeFrame: 0 (predose), 0.5, 1, 2, 3, 4, 6, 8, 10, 12, & 24 hours postdose on Days 10 and 20
measure: Pharmacokinetic Assessment of Midazolam and alpha-hydroxymidazolam
timeFrame: 0 (predose), 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12 & 18 hours postdose on Day -1 and Day 9
Secondary outcomes:
measure: Number of participants with adverse events
timeFrame: Participants will be followed upon taking first dose of study medication until the follow-up visit, an expected average of 5 weeks
Other outcomes:
Locations:
city: Miami
country: United States
facility: SeaView Research, Inc.
state: Florida
Study officials:
affiliation: SeaView Research, Inc.
name: Audrey Martinez, MD
role: PRINCIPAL_INVESTIGATOR
References: