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A Study of Lanabecestat in Healthy Female Participants Taking Oral Contraceptive

Sponsor
Eli Lilly and Company (Industry)
Overall Status
Withdrawn
CT.gov ID
NCT03506399
Collaborator
AstraZeneca (Industry)
0
Enrollment
1
Location
3
Arms
4
Anticipated Duration (Months)
0
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The study will evaluate the effect of oral contraceptive (birth control pill) on the blood level of lanabecestat when both are given together. Side effects will be monitored and documented. This study will last up to 27 days for each participant, not including screening. Screening is required within 42 days prior to first dose.

Condition or Disease Intervention/Treatment Phase
Phase 1

Study Design

Study Type:
Interventional
Actual Enrollment :
0 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
None (Open Label)
Primary Purpose:
Basic Science
Official Title:
Effect of Lanabecestat on the Pharmacokinetics of Ethinyl Estradiol and Levonorgestrel in Healthy Female Subjects
Anticipated Study Start Date :
Jun 1, 2018
Anticipated Primary Completion Date :
Oct 1, 2018
Anticipated Study Completion Date :
Oct 1, 2018

Arms and Interventions

Arm Intervention/Treatment
Experimental: Oral Contraceptive (OC)

Ethinyl estradiol and levonorgestrel administered as a single dose, orally

Drug: Oral Contraceptive
Administered orally
Other Names:
  • Ethinyl Estradiol and Levonorgestrel

    		•
    Experimental: Lanabecestat

    Single oral dose of lanabecestat

    Drug: Lanabecestat
    Administered orally
    Other Names:
  • LY3314814

    		•
    Experimental: Lanabecestat and OC

    A single oral dose of oral contraceptive and single daily doses of lanabecestat

    Drug: Lanabecestat
    Administered orally
    Other Names:
  • LY3314814

    • Drug: Oral Contraceptive
    Administered orally
    Other Names:
  • Ethinyl Estradiol and Levonorgestrel

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Pharmacokinetics (PK): Area Under The Concentration Curve (AUC) of Ethinyl Estradiol [Baseline though 120 hours after administration of the study drug (lanabecestat)]

      PK: AUC of Ethinyl Estradiol

    2. PK: AUC of Levonorgestrel [Baseline though 120 hours after administration of the study drug (lanabecestat)]

      PK: AUC of Levonorgestrel

    3. PK: Maximum Observed Concentration (Cmax) of Ethinyl Estradiol [Baseline though 120 hours after administration of the study drug (lanabecestat)]

      PK: Cmax of Ethinyl Estradiol

    4. PK: Cmax of Levonorgestrel [Baseline though 120 hours after administration of the study drug (lanabecestat)]

      PK: Cmax of Levonorgestrel

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    21 Years to 65 Years
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:

    • Are healthy female participants

    • Women not of childbearing potential; women of childbearing potential using a non-hormonal intrauterine device (IUD)

    • Have a body mass index (BMI) of 17.5 to 32 kilogram per meter square (kg/m²)

    Exclusion Criteria:

    • Have a history of or current significant ophthalmic disease, which includes participants with clinically significant eye abnormalities, particularly any eye problem involving the retina, as determined by the investigator

    • Have vitiligo or any other clinically significant disorder of skin or hair pigmentation, as determined by the investigator

    • Have a history of or current neuropsychiatric disease/condition including psychosis, affective disorder, anxiety disorder, borderline state, or personality disorder

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri, 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST) or speak with your personal physician. Singapore Singapore 138623

    Sponsors and Collaborators

    • Eli Lilly and Company
    • AstraZeneca

    Investigators

    • Study Director: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST), Eli Lilly and Company

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Eli Lilly and Company
    ClinicalTrials.gov Identifier:
    NCT03506399
    Other Study ID Numbers:
    • 16004
    • I8D-MC-AZEK
    First Posted:
    Apr 24, 2018
    Last Update Posted:
    Jun 28, 2018
    Last Verified:
    Jun 1, 2018
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Levonorgestrel
    Ethinyl Estradiol
    Contraceptive Agents
    Contraceptives, Oral
    Estradiol

    Study Results

    No Results Posted as of Jun 28, 2018