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OpenTrials
Completed

NCT Number: NCT02685462

Pharmacokinetic and Safety Study of Cenicriviroc and HMG-CoA Reductase Inhibitors, Caffeine and Digoxin

This is a Phase 1, Open-Label, 3-Period, Single-sequence, Drug-drug Interaction Study in Healthy Subjects to Assess the Effect of Cenicriviroc on the Pharmacokinetics (PK) of HMG-CoA Reductase Inhibitors [Rosuvastatin (ROS), Atorvastatin (ATO) and Simvastatin (SIM)], Caffeine and Digoxin

Completed

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Key information

Conditions

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Miami, Florida, United States

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Be informed of the nature of the study and have provided written informed voluntary consent.
  • Have a BMI ≥ 18.0 and ≤ 35.0 kg/m2.
  • Be in good general health with no clinically relevant abnormalities based on medical history, physical examination, clinical laboratory evaluations (clinical chemistry, hematology, urinalysis), and 12-lead ECG that, in the opinion of the Investigator, would affect subject safety.
  • Be able to communicate effectively with the Investigator and other study center personnel and agree to comply with the study procedures and restrictions.

Exclusion criteria

  • Any disease or condition that might affect drug absorption, metabolism, or excretion, or clinically significant cardiovascular, hematological, renal, hepatic, pulmonary, endocrine, gastrointestinal, immunological, dermatological, neurological, or psychiatric disease, as determined by the Investigator and, if necessary, the Sponsor's Medical Monitor.
  • 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.
  • History of GERD, heartburn, or nausea more than once a month, or any similar symptoms requiring the regular use of antacids, or any use of H2 histamine blockers or proton-pump inhibitors over the past 3 months.
  • History of achlorhydria, pernicious anemia, or peptic ulcers over the past 6 months.
  • Known or suspected hypersensitivity or allergic reaction to any of the components of CVC, ROS, ATO, SIM, Digoxin or Caffeine tablets.
  • History of malignancy, with the exception of cured basal cell or squamous cell carcinoma of the skin.
  • If female, is pregnant or breast feeding, or has a positive pregnancy test result prior to the first dose of study medication.

Treatment and study plan

Rosuvastatin

Drug

Other names: Rosuvastatin 20 mg

atorvastatin

Drug

Other names: Atorvastatin 20 mg

simvastatin

Drug

Other names: Simvastatin 20 mg

Digoxin

Drug

Other names: Digoxin 0.25 mg

Caffeine

Drug

Other names: Caffine 200 mg

Primary outcomes

  1. Pharmacokinetic Assessment of ROS, ATO and Digoxin alone and in the presence of CVC, as measured by maximum plasma concentration (Cmax)

    Time frame: Days 1 and 13

  2. Pharmacokinetic Assessment of SIM alone and in the presence of CVC, as measured by maximum plasma concentration (Cmax)

    Time frame: Days 1 and 12

  3. Pharmacokinetic Assessment of Caffeine alone and in the presence of CVC, as measured by maximum plasma concentration (Cmax)

    Time frame: Days 1 and 13

  4. Pharmacokinetic Assessment of ROS, ATO and Digoxin alone and in the presence of CVC, as measured by minimum plasma concentration (Cmin)

    Time frame: Days 1 and 13

  5. Pharmacokinetic Assessment of ROS, ATO and Digoxin alone and in the presence of CVC, as measured by area under the plasma concentration-time curve (AUC)

    Time frame: Days 1 and 13

  6. Pharmacokinetic Assessment of SIM alone and in the presence of CVC, as measured by minimum plasma concentration (Cmin)

    Time frame: Days 1 and 12

  7. Pharmacokinetic Assessment of SIM alone and in the presence of CVC, as measured by area under the plasma concentration-time curve (AUC)

    Time frame: Days 1 and 12

  8. Pharmacokinetic Assessment of Caffeine alone and in the presence of CVC, as measured by minimum plasma concentration (Cmin)

    Time frame: Days 1 and 13

  9. Pharmacokinetic Assessment of Caffeine alone and in the presence of CVC, as measured by area under the plasma concentration-time curve (AUC)

    Time frame: Days 1 and 13

Secondary outcomes

  1. Evaluation of Adverse Events

    Time frame: 23 days

    Evaluate adverse events

  2. Changes from Baseline in Clinical Laboratory Tests

    Time frame: Baseline and 23 days

    Evaluate changes from baseline in clinical laboratory tests including serum chemistry, and hematology

  3. Changes from Baseline in 12-lead ECGs

    Time frame: Baseline and 23 days

    Evaluate changes from baseline in 12-lead ECGs

  4. Changes from Baseline in Vital Signs

    Time frame: Baseline and 23 days

    Evaluate changes from baseline in vital signs, including blood pressure and pulse rate

  5. Changes from Baseline in Physical Examinations

    Time frame: Baseline and 23 days

    Evaluate changes from baseline in physical examinations

Sponsors and collaborators

Lead sponsor

Tobira Therapeutics, Inc.

Industry

Registry information

Official study title

A Phase 1 Open-Label Study in Healthy Adult Subjects to Assess the Effect of Cenicriviroc Mesylate (CVC) on the Pharmacokinetics (PK) of HMG-CoA Reductase Inhibitors (Rosuvastatin, Atorvastatin and Simvastatin), Caffeine and Digoxin

Important dates

Study start
2016
Primary completion
2016
Study completion
2016
First posted
Feb 18, 2016
Registry last updated
Nov 24, 2017

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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