HealthyPhase 1NCT03506399
A Study of Lanabecestat in Healthy Female Participants Taking Oral Contraceptive
A Phase 1 study testing Lanabecestat and Oral Contraceptive in people with Healthy, run by Eli Lilly and Company at 1 site in Singapore.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 to 65 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Lanabecestat and Oral Contraceptive
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteSingapore
- Study dates
- Jun 2018to Oct 2018
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 65 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Singapore1 site
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, 138623
About this study
Official title: 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.
- Conditions
- Healthy
- Being tested
- Lanabecestat, Oral Contraceptive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LanabecestatDrug
Also called LY3314814
Administered orally
Oral ContraceptiveDrug
Also called Ethinyl Estradiol and Levonorgestrel
Administered orally
| Study group | Role | What they receive |
|---|---|---|
| Oral Contraceptive (OC) | Experimental | Ethinyl estradiol and levonorgestrel administered as a single dose, orally Receives: Drug: Oral Contraceptive |
| Lanabecestat | Experimental | Single oral dose of lanabecestat Receives: Drug: Lanabecestat |
| Lanabecestat and OC | Experimental | A single oral dose of oral contraceptive and single daily doses of lanabecestat Receives: Drug: Lanabecestat; Drug: Oral Contraceptive |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacokinetics (PK): Area Under The Concentration Curve (AUC) of Ethinyl Estradiol
PK: AUC of Ethinyl Estradiol
Measured: Baseline though 120 hours after administration of the study drug (lanabecestat)
PK: AUC of Levonorgestrel
PK: AUC of Levonorgestrel
Measured: Baseline though 120 hours after administration of the study drug (lanabecestat)
PK: Maximum Observed Concentration (Cmax) of Ethinyl Estradiol
PK: Cmax of Ethinyl Estradiol
Measured: Baseline though 120 hours after administration of the study drug (lanabecestat)
PK: Cmax of Levonorgestrel
PK: Cmax of Levonorgestrel
Measured: Baseline though 120 hours after administration of the study drug (lanabecestat)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2018
- Study startJun 2018 (estimated)
- Primary completionOct 2018 (estimated)
- Study completionOct 2018 (estimated)
Why it stopped: Stopped for futility. Phase 3 studies not likely to meet primary endpoints.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by Eli Lilly and CompanyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eli Lilly and Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- AstraZeneca
- Responsible party
- Sponsor
- Investigators
- 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), Study director, Eli Lilly and Company
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03506399
- Sponsor's protocol ID
- 16004
- Other IDs
- I8D-MC-AZEK
- Status last verified
- Jun 2018
- First submitted
- 20 Apr 2018
- Last updated
- 28 Jun 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Lanabecestat on the Pharmacokinetics of Ethinyl Estradiol and Levonorgestrel in Healthy Female Subjects
- ClinicalTrials.gov ID
- NCT03506399
- Acronym / sponsor ID
- 16004
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Stopped for futility. Phase 3 studies not likely to meet primary endpoints.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Eli Lilly and CompanyIndustry (pharma, biotech, devices)
- Collaborators
- AstraZeneca
- Study start
- Jun 2018 (estimated)
- Primary completion
- Oct 2018 (estimated)
- Study completion
- Oct 2018 (estimated)
- First posted
- 24 Apr 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Oral Contraceptive (OC) | Experimental | Drug: Oral ContraceptiveEthinyl estradiol and levonorgestrel administered as a single dose, orally |
| Lanabecestat | Experimental | Drug: LanabecestatSingle oral dose of lanabecestat |
| Lanabecestat and OC | Experimental | Drug: Lanabecestat, Drug: Oral ContraceptiveA single oral dose of oral contraceptive and single daily doses of lanabecestat |
Who may qualify
- Ages
- 21 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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)
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LanabecestatAlso: LY3314814Administered orally | Drug | Lanabecestat, Lanabecestat and OC |
| Oral ContraceptiveAlso: Ethinyl Estradiol and LevonorgestrelAdministered orally | Drug | Lanabecestat and OC, Oral Contraceptive (OC) |
Primary outcome
Pharmacokinetics (PK): Area Under The Concentration Curve (AUC) of Ethinyl Estradiol
Time frame: Baseline though 120 hours after administration of the study drug (lanabecestat)
PK: AUC of Ethinyl Estradiol
PK: AUC of Levonorgestrel
Time frame: Baseline though 120 hours after administration of the study drug (lanabecestat)
PK: AUC of Levonorgestrel
PK: Maximum Observed Concentration (Cmax) of Ethinyl Estradiol
Time frame: Baseline though 120 hours after administration of the study drug (lanabecestat)
PK: Cmax of Ethinyl Estradiol
PK: Cmax of Levonorgestrel
Time frame: Baseline though 120 hours after administration of the study drug (lanabecestat)
PK: Cmax of Levonorgestrel
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jun 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
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) study director
Eli Lilly and Company
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Lanabecestat and Oral Contraceptive in people with Healthy, run by Eli Lilly and Company at 1 site in Singapore.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 28 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Singapore. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pharmacokinetics (PK): Area Under The Concentration Curve (AUC) of Ethinyl Estradiol (time frame: Baseline though 120 hours after administration of the study drug (lanabecestat)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jun 2018.