NCT01827540

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Mar 2013

Shorter than P25 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2013

Completed
24 days until next milestone

First Submitted

Initial submission to the registry

March 25, 2013

Completed
15 days until next milestone

First Posted

Study publicly available on registry

April 9, 2013

Completed
22 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2013

Completed
Last Updated

April 9, 2014

Status Verified

April 1, 2014

Enrollment Period

2 months

First QC Date

March 25, 2013

Last Update Submit

April 8, 2014

Conditions

HIV-infection/AIDS

Keywords

HIV/AIDSCenicriviroc (CVC)Dolutegravir (DTG)MidazolamHealthy Subjects

Outcome Measures

Primary Outcomes (3)

  • 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.

    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.

    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.

    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 (1)

  • Number of participants with adverse events

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

Study Arms (2)

Cenicriviroc + Midazolam, and CVC + DTG

EXPERIMENTAL

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.

Drug: CenicrivirocDrug: DolutegravirDrug: Midazolam

Dolutegravir , and DTG + CVC

EXPERIMENTAL

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

Drug: CenicrivirocDrug: Dolutegravir

Interventions

CenicrivirocDRUG
Also known as: CVC
Cenicriviroc + Midazolam, and CVC + DTGDolutegravir , and DTG + CVC
DolutegravirDRUG
Also known as: DTG
Cenicriviroc + Midazolam, and CVC + DTGDolutegravir , and DTG + CVC
MidazolamDRUG
Also known as: Dormicum, Hypnovel, Versed
Cenicriviroc + Midazolam, and CVC + DTG

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

SeaView Research, Inc.

Miami, Florida, 33126, United States

Location

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome

Interventions

cenicrivirocdolutegravirMidazolam

Condition Hierarchy (Ancestors)

HIV InfectionsBlood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesSlow Virus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System Diseases

Intervention Hierarchy (Ancestors)

BenzodiazepinesBenzazepinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Officials

  • Audrey Martinez, MD

    SeaView Research, Inc.

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 25, 2013

First Posted

April 9, 2013

Study Start

March 1, 2013

Primary Completion

May 1, 2013

Study Completion

May 1, 2013

Last Updated

April 9, 2014

Record last verified: 2014-04

Locations

US(1)