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Drug-drug Interaction Study Between EDP-305, Midazolam, Caffeine and Rosuvastatin in Healthy Volunteers.

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ClinicalTrials.gov Identifier: NCT03187496
Recruitment Status : Completed
First Posted : June 15, 2017
Last Update Posted : August 21, 2017
Sponsor:
Information provided by (Responsible Party):
Enanta Pharmaceuticals

Brief Summary:
A non-randomized, multiple-dose, open-label, single sequence study to evaluate effect of concomitant administration of EDP-305 on the pharmacokinetics and safety of midazolam, caffeine, and rosuvastatin in healthy human volunteers.

Condition or disease Intervention/treatment Phase
NASH Drug: Midazolam Drug: Caffeine Drug: Rosuvastatin Drug: EDP-305 Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: A Non-Randomized, Multiple-Dose, Open-Label, Single Sequence Study to Evaluate the Effect of Concomitant Administration of EDP-305 on the Pharmacokinetics and Safety of Midazolam, Caffeine, and Rosuvastatin in Healthy Human Volunteers
Actual Study Start Date : May 11, 2017
Actual Primary Completion Date : June 1, 2017
Actual Study Completion Date : June 14, 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Single Arm Drug: Midazolam
Each subject will receive midazolam on Days 1 and 12.

Drug: Caffeine
Each subject will receive caffeine on Days 1 and 12.

Drug: Rosuvastatin
Each subject will receive rosuvastatin on Days 2 and 13.

Drug: EDP-305
Each subject will receive EDP-305 on Days 5 through 15.




Primary Outcome Measures :
  1. Cmax of midazolam, caffeine, and rosuvastatin with and without the coadministration of EDP-305. [ Time Frame: Up to 17 Days ]
  2. AUC of midazolam, caffeine, and rosuvastatin with and without the coadministration of EDP-305. [ Time Frame: Up to 17 days ]

Secondary Outcome Measures :
  1. Cmax of 1'-hydroxymidazolam, paraxanthine and N-desmethyl-rosuvastatin with and without the coadministration of EDP-305. [ Time Frame: Up to 17 days ]
  2. AUC of 1'-hydroxymidazolam, paraxanthine and N-desmethyl-rosuvastatin with and without the coadministration of EDP-305. [ Time Frame: Up to 17 days ]
  3. Tmax of midazolam, 1'-hydroxymidazolam, caffeine, paraxanthine, rosuvastatin and N-desmethyl-rosuvastatin with and without the coadministration of EDP-305. [ Time Frame: Up to 17 days ]
  4. t1/2 of midazolam, 1'-hydroxymidazolam, caffeine, paraxanthine, rosuvastatin and N-desmethyl-rosuvastatin with and without the coadministration of EDP-305. [ Time Frame: Up to 17 days ]
  5. CL/F of midazolam, caffeine and rosuvastatin with and without the coadministration of EDP-305. [ Time Frame: Up to 17 days ]
  6. Vd/F of midazolam, 1'-hydroxymidazolam, caffeine, paraxanthine, rosuvastatin and N-desmethyl-rosuvastatin with and without the coadministration of EDP-305. [ Time Frame: Up to 17 days ]
  7. AUC ratios for 1'-hydroxymidazolam/midazolam, paraxanthine/caffeine, and N-desmethyl-rosuvastatin/rosuvastatin. [ Time Frame: Up to 17 days ]
  8. Safety measured by adverse events, physical exams, vital signs, 12-lead electrocardiograms (ECGs) and clinical lab results (including chemistry, hematology, and urinalysis). [ Time Frame: Up to 17 days ]


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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • An informed consent document signed and dated by the subject.
  • Healthy male and female subjects of any ethnic origin between the ages of 18 and 55 years, inclusive.
  • Female subjects must be of non-childbearing potential.

Exclusion Criteria:

  • Clinically relevant evidence or history of illness or disease.
  • Pregnant or nursing females.
  • History of febrile illness within 7 days prior to the first dose of study drug or subjects with evidence of active infection.
  • A positive urine drug screen at screening or Day -1.
  • Current tobacco smokers or use of tobacco within 3 months prior to screening.
  • Any condition possibly affecting drug absorption (e.g., gastrectomy, cholecystectomy).
  • History of regular alcohol consumption.
  • Participation in a clinical trial within 30 days prior to the first dose of study drug.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03187496


Locations
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United States, Kansas
Pharmaceutical Research Associates, Inc.,
Lenexa, Kansas, United States, 66219
Sponsors and Collaborators
Enanta Pharmaceuticals
Investigators
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Principal Investigator: Daniel Dickerson, MD Pharmaceutical Research Associates

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Responsible Party: Enanta Pharmaceuticals
ClinicalTrials.gov Identifier: NCT03187496     History of Changes
Other Study ID Numbers: EDP 305-004
First Posted: June 15, 2017    Key Record Dates
Last Update Posted: August 21, 2017
Last Verified: August 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: When the clinical study report has been submitted to the appropriate Regulatory authorities, a lay person summary will be provided to all study subjects by mail or email.

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Enanta Pharmaceuticals:
drug-drug interaction

Additional relevant MeSH terms:
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Midazolam
Caffeine
Rosuvastatin Calcium
Adjuvants, Anesthesia
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Anti-Anxiety Agents
Tranquilizing Agents
Psychotropic Drugs
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
GABA Modulators
GABA Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors
Central Nervous System Stimulants
Phosphodiesterase Inhibitors
Purinergic P1 Receptor Antagonists
Purinergic Antagonists
Purinergic Agents