NCT03783897

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

Trial Health

87
On Track

Trial Health Score

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

Enrollment
43

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Nov 2018

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

November 27, 2018

Completed
22 days until next milestone

First Submitted

Initial submission to the registry

December 19, 2018

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 21, 2018

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 4, 2019

Completed
14 days until next milestone

Study Completion

Last participant's last visit for all outcomes

June 18, 2019

Completed
Last Updated

July 24, 2019

Status Verified

July 1, 2019

Enrollment Period

6 months

First QC Date

December 19, 2018

Last Update Submit

July 23, 2019

Conditions

NASH - Nonalcoholic Steatohepatitis

Keywords

OC DDI, drug-drug interaction, oral contraceptive

Outcome Measures

Primary Outcomes (2)

  • Area under the plasma concentration-time (AUC0-τ) curve for OC with and without coadministration with EDP-305

    Day 21 (cycle 2 and cycle 3)

  • Cmax for OC with and without coadministration with EDP-305

    Day 21 (cycle 2 and cycle 3)

Secondary Outcomes (3)

  • Area under the plasma concentration-time (AUC0-τ) curve for EDP-305 when coadministration with OC

    Days 14, 20-22 (cycle 3)

  • Cmax for EDP-305 when coadministration with OC

    Days 14, 20-22 (cycle 3)

  • Safety measured by adverse events

    Approximately 91 days

Study Arms (1)

EDP-305 and Oral Contraceptive

EXPERIMENTAL
Drug: EDP-305Drug: Oral Contraceptive

Interventions

EDP-305DRUG

Subjects will receive EDP-305 on on Days 11 through 21 of cycle 3

EDP-305 and Oral Contraceptive
Oral ContraceptiveDRUG

Subjects will receive active Oral Contraceptive on Days 1-21 and inert OC on Days 22-28 of cycles 1, 2 and 3

Also known as: ethinyl estradiol [EE] and norgestimate [NGM])
EDP-305 and Oral Contraceptive

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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:
  • Women aged \< 21 years: no documentation required
  • Women aged 21 to 29: normal Pap smear test result within previous 3 years
  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Covance Clinical Research Unit

Madison, Wisconsin, 53704, United States

Location

MeSH Terms

Conditions

Non-alcoholic Fatty Liver Disease

Interventions

EDP-305Contraceptives, OralEthinyl Estradiolnorgestimate

Condition Hierarchy (Ancestors)

Fatty LiverLiver DiseasesDigestive System Diseases

Intervention Hierarchy (Ancestors)

Contraceptive Agents, FemaleContraceptive AgentsReproductive Control AgentsPhysiological Effects of DrugsPharmacologic ActionsChemical Actions and UsesTherapeutic UsesNorpregnatrienesNorpregnanesNorsteroidsSteroidsFused-Ring CompoundsPolycyclic CompoundsEstrogenic Steroids, AlkylatedEstradiol CongenersGonadal Steroid HormonesGonadal HormonesHormonesHormones, Hormone Substitutes, and Hormone Antagonists

Study Officials

  • Enanta Pharmaceuticals, Inc

    Enanta Pharmaceuticals, Inc

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 19, 2018

First Posted

December 21, 2018

Study Start

November 27, 2018

Primary Completion

June 4, 2019

Study Completion

June 18, 2019

Last Updated

July 24, 2019

Record last verified: 2019-07

Locations

US(1)