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A Drug-drug Interaction Study to Investigate the Effect of Coadministration of EDP-305 on the PK of a Combined Oral Contraceptive in Healthy Female Subjects

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ClinicalTrials.gov Identifier: NCT03783897
Recruitment Status : Completed
First Posted : December 21, 2018
Last Update Posted : July 24, 2019
Sponsor:
Collaborator:
Covance
Information provided by (Responsible Party):
Enanta Pharmaceuticals

Brief Summary:
A Phase 1, Open-label, Fixed-sequence Study to Investigate the Effects of EDP 305 on the Pharmacokinetics of a Combined Oral Contraceptive in Healthy Adult Female Subjects

Condition or disease Intervention/treatment Phase
NASH - Nonalcoholic Steatohepatitis Drug: EDP-305 Drug: Oral Contraceptive Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 43 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: A Phase 1, Open-label, Fixed-sequence Study to Investigate the Effects of EDP 305 on the Pharmacokinetics of a Combined Oral Contraceptive in Healthy Adult Female Subjects
Actual Study Start Date : November 27, 2018
Actual Primary Completion Date : June 4, 2019
Actual Study Completion Date : June 18, 2019


Arm Intervention/treatment
Experimental: EDP-305 and Oral Contraceptive Drug: EDP-305
Subjects will receive EDP-305 on on Days 11 through 21 of cycle 3

Drug: Oral Contraceptive
Subjects will receive active Oral Contraceptive on Days 1-21 and inert OC on Days 22-28 of cycles 1, 2 and 3
Other Name: ethinyl estradiol [EE] and norgestimate [NGM])




Primary Outcome Measures :
  1. Area under the plasma concentration-time (AUC0-τ) curve for OC with and without coadministration with EDP-305 [ Time Frame: Day 21 (cycle 2 and cycle 3) ]
  2. Cmax for OC with and without coadministration with EDP-305 [ Time Frame: Day 21 (cycle 2 and cycle 3) ]

Secondary Outcome Measures :
  1. Area under the plasma concentration-time (AUC0-τ) curve for EDP-305 when coadministration with OC [ Time Frame: Days 14, 20-22 (cycle 3) ]
  2. Cmax for EDP-305 when coadministration with OC [ Time Frame: Days 14, 20-22 (cycle 3) ]
  3. Safety measured by adverse events [ Time Frame: Approximately 91 days ]


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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Females of childbearing potential, 18 to 45 years of age, inclusive. Follicle-stimulating hormone levels may be used to confirm premenopausal status, including females who have had a hysterectomy with ovaries still intact. Women who otherwise meet inclusion criteria and who have had tubal ligation, tubal occlusion, or bilateral salpingectomy will be allowed.
  • Body mass index between 18.0 and 32.0 kg/m2, inclusive.
  • In good health, determined by no clinically significant findings from medical history, physical examination, 12 lead ECG, vital signs measurements, and clinical laboratory evaluations at Screening and Day -1 of the Lead-in Period
  • Must not be pregnant or lactating, and must agree to use contraception
  • Subjects must have documentation of normal results of up-to-date cervical cancer screening as specified in the American College of Obstetricians and Gynecologists guidelines:

    1. Women aged < 21 years: no documentation required
    2. Women aged 21 to 29: normal Pap smear test result within previous 3 years
    3. Women aged 30 to 45: normal Pap smear test result and negative high-risk human papilloma virus test within previous 5 years, OR normal Pap smear test result within previous 3 years If documented results are not available at Screening, the subject must provide documentation of normal results prior to Day -1 of the Lead-in Period.
  • Able to comprehend and willing to sign an ICF.
  • Willing and able to adhere to assessments, prohibitions, and restrictions as described in this protocol.

Exclusion Criteria:

  • Significant history or clinical manifestation of any metabolic, allergic, dermatological, hepatic, renal, hematological, pulmonary, cardiovascular, GI, neurological, respiratory, endocrine, or psychiatric disorder, as determined by the Investigator (or designee).
  • Are pregnant, breastfeeding, or are planning to conceive during the study.
  • Have been administered injectable contraceptives within 12 months prior to Day -1 of the Lead in Period, or had exposure to a hormonal intrauterine device or topical controlled delivery contraceptives (patch) within 3 months prior to Day -1 of the Lead-in Period.

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): NCT03783897


Locations
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United States, Wisconsin
Covance Clinical Research Unit
Madison, Wisconsin, United States, 53704
Sponsors and Collaborators
Enanta Pharmaceuticals
Covance
Investigators
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Study Director: Enanta Pharmaceuticals, Inc Enanta Pharmaceuticals, Inc

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Responsible Party: Enanta Pharmaceuticals
ClinicalTrials.gov Identifier: NCT03783897     History of Changes
Other Study ID Numbers: EDP 305-008
First Posted: December 21, 2018    Key Record Dates
Last Update Posted: July 24, 2019
Last Verified: July 2019

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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:
OC DDI, drug-drug interaction, oral contraceptive
Additional relevant MeSH terms:
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Fatty Liver
Non-alcoholic Fatty Liver Disease
Liver Diseases
Digestive System Diseases
Contraceptive Agents
Contraceptives, Oral
Contraceptives, Oral, Combined
Ethinyl Estradiol
Estrogens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Reproductive Control Agents
Contraceptive Agents, Female