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Completed

NCT Number: NCT01827540

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

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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Key information

Conditions

HIV-infection/Aids Acquired Immunodeficiency Syndrome Blood-Borne Infections Communicable Diseases Genital Diseases HIV Infections Immune System Diseases Immunologic Deficiency Syndromes Infections Lentivirus Infections RNA Virus Infections Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Slow Virus Diseases Urogenital Diseases Virus Diseases

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

SeaView Research, Inc.

Miami, Florida, 33126, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Cenicriviroc

Drug

Other names: CVC

Dolutegravir

Drug

Other names: DTG

midazolam

Drug

Other names: Dormicum, Hypnovel, Versed

Primary outcomes

  1. Pharmacokinetic Assessment of Cenicriviroc

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

    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.

  2. Pharmacokinetic Assessment of Dolutegravir

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

    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.

  3. Pharmacokinetic Assessment of Midazolam and alpha-hydroxymidazolam

    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

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

Secondary outcomes

  1. Number of participants with adverse events

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

    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).

Sponsors and collaborators

Lead sponsor

Tobira Therapeutics, Inc.

Industry

Collaborators

  • ViiV Healthcare

Registry information

Official study 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

Important dates

Study start
2013
Primary completion
2013
Study completion
2013
First posted
Apr 9, 2013
Registry last updated
Apr 9, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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