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

Tobira Therapeutics, Inc.20 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Masking

NONE

Enrollment

Conditions

HIV-infection/AIDS

Interventions

CenicrivirocDRUG

DolutegravirDRUG

MidazolamDRUG

Eligibility

Sex: ALLMin age: 18 YearsMax age: 55 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

SeaView Research, Inc.

Miami, Florida, United States

Outcomes

Primary Outcomes

Pharmacokinetic Assessment of Cenicriviroc

PK profile will be calculated based on CVC exposure. Trough (predose) CVC plasma samples will be obtained prior to dosing on Days 2-9 \& 12-19.

Time frame: 0 (predose), 0.5, 1, 2, 3, 4, 6, 8, 10, 12, & 24 hours postdose on Days 10 and 20

Pharmacokinetic Assessment of Dolutegravir

PK profile will be calculated based on DTG exposure. Trough (predose) DTG plasma samples will be obtained prior to dosing on Days 2-9 \& 12-19.

Time frame: 0 (predose), 0.5, 1, 2, 3, 4, 6, 8, 10, 12, & 24 hours postdose on Days 10 and 20

Pharmacokinetic Assessment of Midazolam and alpha-hydroxymidazolam

PK profile will be calculated (Group 1 only) based on plasma midazolam \& alpha-hydroxymidazolam exposure.

Time frame: 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

Number of participants with adverse events

Physical examinations, vital signs, ECGs, clinical laboratory tests, and AEs or serious AEs (SAEs) will be assessed at specified time points according to the Schedule of Procedures in the protocol. In addition, arterial oxygen saturation will be monitored by pulse oximetry for at least 2 hours after administration of midazolam on Days -1 and 9 in Group 1. For both groups, a final follow-up visit will occur 14 days (±3 days) after the last dose of study medication, or at the time of early termination (if applicable) to evaluate any remaining safety issue(s).

Time frame: Participants will be followed upon taking first dose of study medication until the follow-up visit, an expected average of 5 weeks

Data from ClinicalTrials.gov

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