- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03506399
A Study of Lanabecestat in Healthy Female Participants Taking Oral Contraceptive
June 26, 2018 updated by: Eli Lilly and Company
Effect of Lanabecestat on the Pharmacokinetics of Ethinyl Estradiol and Levonorgestrel in Healthy Female Subjects
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.
Study Overview
Status
Withdrawn
Conditions
Intervention / Treatment
Study Type
Interventional
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Singapore, Singapore, 138623
- 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.
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
21 years to 65 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Female
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: BASIC_SCIENCE
- Allocation: RANDOMIZED
- Interventional Model: CROSSOVER
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Oral Contraceptive (OC)
Ethinyl estradiol and levonorgestrel administered as a single dose, orally
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Administered orally
Other Names:
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EXPERIMENTAL: Lanabecestat
Single oral dose of lanabecestat
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Administered orally
Other Names:
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EXPERIMENTAL: Lanabecestat and OC
A single oral dose of oral contraceptive and single daily doses of lanabecestat
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Administered orally
Other Names:
Administered orally
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Pharmacokinetics (PK): Area Under The Concentration Curve (AUC) of Ethinyl Estradiol
Time Frame: Baseline though 120 hours after administration of the study drug (lanabecestat)
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PK: AUC of Ethinyl Estradiol
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Baseline though 120 hours after administration of the study drug (lanabecestat)
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PK: AUC of Levonorgestrel
Time Frame: Baseline though 120 hours after administration of the study drug (lanabecestat)
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PK: AUC of Levonorgestrel
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Baseline though 120 hours after administration of the study drug (lanabecestat)
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PK: Maximum Observed Concentration (Cmax) of Ethinyl Estradiol
Time Frame: Baseline though 120 hours after administration of the study drug (lanabecestat)
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PK: Cmax of Ethinyl Estradiol
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Baseline though 120 hours after administration of the study drug (lanabecestat)
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PK: Cmax of Levonorgestrel
Time Frame: Baseline though 120 hours after administration of the study drug (lanabecestat)
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PK: Cmax of Levonorgestrel
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Baseline though 120 hours after administration of the study drug (lanabecestat)
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ANTICIPATED)
June 1, 2018
Primary Completion (ANTICIPATED)
October 1, 2018
Study Completion (ANTICIPATED)
October 1, 2018
Study Registration Dates
First Submitted
April 20, 2018
First Submitted That Met QC Criteria
April 20, 2018
First Posted (ACTUAL)
April 24, 2018
Study Record Updates
Last Update Posted (ACTUAL)
June 28, 2018
Last Update Submitted That Met QC Criteria
June 26, 2018
Last Verified
June 1, 2018
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Physiological Effects of Drugs
- Hormones
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Estrogens
- Contraceptive Agents, Hormonal
- Reproductive Control Agents
- Contraceptive Agents, Female
- Contraceptives, Oral, Synthetic
- Contraceptives, Oral, Hormonal
- Levonorgestrel
- Estradiol
- Contraceptive Agents
- Ethinyl Estradiol
- Contraceptives, Oral
Other Study ID Numbers
- 16004
- I8D-MC-AZEK (OTHER: Eli Lilly and Company)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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