Healthy SubjectsPhase 1NCT03451110
Study to Assess the Pharmacokinetic Drug-Drug Interactions of Lemborexant When Coadministered With an Oral Contraceptive, Famotidine, or Fluconazole in Healthy Subjects
A Phase 1 study testing lemborexant, Loestrin and famotidine in people with Healthy Subjects, run by Eisai Inc. at 1 site in United States.
Trial summary
This study will be conducted to evaluate the effect of lemborexant 10 milligrams (mg) (at steady state) on the pharmacokinetics (PK) of a single-dose combined oral contraceptive, Loestrin 1.5/30 (containing 0.030 mg of ethinyl estradiol and 1.5 mg of norethindrone), and to evaluate the effect of fluconazole 200 mg (at… Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Subjects
- What is being tested?
- lemborexant, Loestrin and famotidine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Feb 2018to 23 Mar 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 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Inclusion Criteria for All Participants (Part 1 - Oral Contraceptive; Part 2 - Famotidine; Part 3 - Fluconazole)
- Participants who meet all of the following inclusion criteria will be eligible for participation in the study:
- Body mass index >18 and ≤32 kilograms per meters squared at Screening
- Are willing and able to comply with all aspects of the protocol
- Provide written informed consent
- Additional Inclusion Criteria for Part 1 - Oral Contraceptive
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- Healthy female participants, ages 18 to 44 years old (inclusive) at Screening
- Must not be taking any form of hormonal contraceptives, including hormonal intra-uterine device, for at least 8 weeks prior to dosing
- Additional Inclusion Criteria (Part 2 - Famotidine; Part 3 - Fluconazole)
- -Healthy male or female, age ≥18 years and ≤55 years old at the time of informed consent
Who cannot join
- Known contraindication to Loestrin (only for Part 1), to Famotidine (only for Part 2), or to Fluconazole (only for Part 3)
- Females who are breastfeeding or pregnant at Screening or Baseline.
- Females of childbearing potential. NOTE: All females will be considered to be of childbearing potential unless they are postmenopausal (amenorrheic for at least 12 consecutive months, in the appropriate age group, and without other known or suspected cause) or have been sterilized surgically (i.e., bilateral tubal ligation, total hysterectomy, or bilateral oophorectomy, all with surgery at least 1 month before dosing).
- Clinically significant illness that requires medical treatment within 8 weeks or a clinically significant infection that requires medical treatment within 4 weeks of dosing
- Presence of significant illness that requires treatment or may influence the study assessments (e.g. psychiatric disorders, disorders of the gastrointestinal tract, liver, kidney, respiratory system, endocrine system, hematological system, neurological system, cardiovascular system, or a congenital abnormality)
- Any history of abdominal surgery that may affect PK profiles of lemborexant (eg, hepatectomy, nephrectomy, digestive organ resection) at Screening
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- Any other clinically abnormal symptom or organ impairment found by medical history, physical examinations, vital signs, electrocardiogram (ECG) finding, or laboratory test results that requires medical treatment at Screening or Baseline
- A prolonged QT/corrected QT (QTc) interval (QTc >450 milliseconds) demonstrated on ECG at Screening or Baseline
- Persistent systolic blood pressure (BP) >160 millimeters of mercury (mmHg) or diastolic BP >100 mmHg at Screening or Baseline (based on BP measured on at least 3 occasions over 2 weeks)
- Persistent heart rate (HR) of <50 beats per minute (beats/min) or >90 beats/min at Screening or Baseline (based on HR measured on at least 3 occasions over 2 weeks)
- Known history of clinically significant drug allergy at Screening or Baseline
- Known history of food allergies or presently experiencing significant seasonal or perennial allergy at Screening or Baseline
- Known to be human immunodeficiency virus positive
- Active viral hepatitis (B or C) as demonstrated by positive serology at Screening
- History of drug or alcohol dependency or abuse within the 2 years before Screening
- Participants who smoke or have used tobacco or nicotine-containing products within 4 weeks before dosing
- Any suicidal ideation with intent with or without a plan at Screening or within 6 months of Screening (ie, for Part 1 answering "Yes" to questions 4 or 5 on the Suicidal Ideation section of the Columbia-Suicide Severity Rating Scale) or any suicidal behavior in the past 10 years.
- Currently enrolled in another clinical trial or used any investigational drug or device within 30 days (or 5 half-lives, whichever is longer) preceding informed consent
- Engagement in strenuous exercise within 2 weeks before check-in (e.g., marathon runners, weight lifters)
- Intake of caffeinated beverages or caffeinated food within 72 hours before dosing and during the course of the study
- Intake of food supplements (including herbal preparations), foods, or beverages that may affect cytochrome P4503A4 enzyme (e.g., alcohol, grapefruit, grapefruit juice, grapefruit-containing beverages, apple or orange juice, vegetables from the mustard green family [e.g., kale, broccoli, watercress, collard greens, kohlrabi, Brussels sprouts, mustard], and charbroiled meats) within 1 week before dosing
- Intake of herbal preparations containing St. John's Wort within 4 weeks before dosing
- Intake of prescription or over-the-counter medications within 14 days (or 5 half-lives, whichever is longer) before dosing unless the Principal Investigator and medical monitor consider that they do not compromise participant safety or study assessments
- A positive urine drug test, a positive breathalyzer alcohol test, or, if appropriate, a positive serum pregnancy test
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A 3-Part, Open-label Study to Assess the Pharmacokinetic Drug-Drug Interactions of Lemborexant When Coadministered With an Oral Contraceptive, Famotidine, or Fluconazole in Healthy Subjects
This study will be conducted to evaluate the effect of lemborexant 10 milligrams (mg) (at steady state) on the pharmacokinetics (PK) of a single-dose combined oral contraceptive, Loestrin 1.5/30 (containing 0.030 mg of ethinyl estradiol and 1.5 mg of norethindrone), and to evaluate the effect of fluconazole 200 mg (at steady state) and a single dose of famotidine 40 mg (an H2 blocker) on the PK of a single oral dose of lemborexant 10 mg.
- Conditions
- Healthy Subjects
- Being tested
- lemborexant, Loestrin, famotidine, fluconazole
- Keywords
- Drug-Drug Interactions, Lemborexant, Oral Contraceptive, Famotidine, Fluconazole, Pharmacokinetics, Proton pump inhibitors, CYP3A inhibitors
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
lemborexantDrug
Also called E2006
oral tablet
LoestrinDrug
oral tablet
famotidineDrug
oral tablet
fluconazoleDrug
oral tablet
| Study group | Role | What they receive |
|---|---|---|
| Part 1: Lemborexant plus Loestrin | Experimental | Healthy female participants will receive a single oral dose of Loestrin 1.5/30 (containing ethinyl estradiol [EE] 0.030 milligrams [mg] and norethindrone [NE] 1.5 mg) in the evening of Day 1 after a fast of at least 3 hours. After a washout period of at least 4 days, participants will receive 10 mg lemborexant orally for 10 days. Lemborexant will continue to be administered in the evening on Days 15 through 18, followed by a single oral dose of Loestrin on Day 15 when administered with lemborexant after fasting in the evening for at least 3 hours. Receives: Drug: lemborexant; Drug: Loestrin |
| Part 2: Lemborexant plus Famotidine | Experimental | Healthy participants will receive a single oral dose of 10 mg lemborexant in the morning of Day 1 after an overnight fast of at least 10 hours. On Day 15, participants will receive a single oral dose of 40 mg famotidine, followed at least 2 hours later by a single dose of 10 mg lemborexant. After a washout period of up to 14 days participants will receive 10 mg lemborexant orally for 10 days. Receives: Drug: lemborexant; Drug: famotidine |
| Part 3: Lemborexant plus Fluconazole | Experimental | Healthy participants will receive a single oral dose of 10 mg lemborexant in the morning of Day 1 after an overnight fast of at least 10 hours. After a washout interval of approximately 10 days, on Day 11, participants will be administered 400 mg fluconazole followed by 200 mg fluconazole once daily from Days 12 to 26. During this time a single dose of 10 mg lemborexant will be administered following an overnight fast of at least 10 hours along with fluconazole on Day 15 only. Receives: Drug: lemborexant; Drug: fluconazole |
What is being measured
The primary outcome is the main question the study is designed to answer.
Part 1 (Lemborexant plus Loestrin): Mean maximum observed concentration (Cmax) of lemborexant and metabolites
Measured: Blood samples for lemborexant and metabolite assessment will be obtained at predose and 0.5 (30 minutes), 1, 1.5, 2, 3, 4, 5, 6, 8, 12, and 24 hours postdose on Days 14 and 15.
Part 1 (Lemborexant plus Loestrin): Mean predose drug concentration (Cmin) of lemborexant and metabolites
Measured: Blood samples for lemborexant and metabolite assessment will be obtained at predose and 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, and 24 hours postdose on Days 14 and 15.
Part 1 (Lemborexant plus Loestrin): Mean time to reach maximum (peak) drug concentration following drug administration (Tmax) of lemborexant and metabolites
Measured: Blood samples for lemborexant and metabolite assessment will be obtained at predose and 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, and 24 hours postdose on Days 14 and 15.
Part 1 (Lemborexant plus Loestrin): Mean area under the concentration-time curve from zero time to 24 hours postdose (AUC[0-24h]) of lemborexant and metabolites
Measured: Blood samples for lemborexant and metabolite assessment will be obtained at predose and 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, and 24 hours postdose on Days 14 and 15.
Part 2 (Lemborexant plus Famotidine): Mean Cmax of lemborexant and metabolites
Measured: Blood samples for lemborexant and metabolite assessment will be obtained at predose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72, 120, 168, and 216 hours after dosing on Days 1 and 15.
Part 2 (Lemborexant plus Famotidine): Mean Tmax of lemborexant and metabolites
Measured: Blood samples for lemborexant and metabolite assessment will be obtained at predose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72, 120, 168, and 216 hours after dosing on Days 1 and 15.
Part 2 (Lemborexant plus Famotidine): Mean AUC(0-24h) of lemborexant and metabolites
Measured: Blood samples for lemborexant and metabolite assessment will be obtained at predose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72, 120, 168, and 216 hours after dosing on Days 1 and 15.
Part 2 (Lemborexant plus Famotidine): Mean AUC from zero time to 72 hours postdose (AUC[0-72h]) of lemborexant and metabolites
Measured: Blood samples for lemborexant and metabolite assessment will be obtained at predose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72, 120, 168, and 216 hours after dosing on Days 1 and 15.
Part 2 (Lemborexant plus Famotidine): Mean AUC from zero time to last measurable time (AUC[0-t]) of lemborexant and metabolites
Measured: Blood samples for lemborexant and metabolite assessment will be obtained at predose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72, 120, 168, and 216 hours after dosing on Days 1 and 15.
Part 2 (Lemborexant plus Famotidine): Mean AUC from zero time extrapolated to infinite time (AUC[0-inf]) of lemborexant and metabolites
Measured: Blood samples for lemborexant and metabolite assessment will be obtained at predose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72, 120, 168, and 216 hours after dosing on Days 1 and 15.
Part 2 (Lemborexant plus Famotidine): Mean terminal elimination half-life (t1/2) of lemborexant and metabolites following the last dose
Measured: Blood samples for lemborexant and metabolite assessment will be obtained at predose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72, 120, 168, and 216 hours after dosing on Days 1 and 15.
Part 3 (Lemborexant plus Fluconazole): Mean Cmax of lemborexant and metabolites
Day 1 at predose and at approximately 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 12 hours postdose. At approximately 24, 48, and 72 (Days 2 to 4); 120 (Day 6); 168 (Day 8); 216 (Day 10) hours after the first dose. Day 15 at predose and at approximately 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 12 hours after the second dose. At approximately 24, 48, and 72 (Days 16 to 18); 120 (Day 20); 168 (Day 22); 216 (Day 24); 288 (Day 27) hours after the second dose.
Measured: Blood samples for lemborexant and metabolite assessment will be obtained on Days 1 to 27.
Part 3 (Lemborexant plus Fluconazole): Mean Tmax of lemborexant and metabolites
Day 1 at predose and at approximately 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 12 hours postdose. At approximately 24, 48, and 72 (Days 2 to 4); 120 (Day 6); 168 (Day 8); 216 (Day 10) hours after the first dose. Day 15 at predose and at approximately 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 12 hours after the second dose. At approximately 24, 48, and 72 (Days 16 to 18); 120 (Day 20); 168 (Day 22); 216 (Day 24); 288 (Day 27) hours after the second dose.
Measured: Blood samples for lemborexant and metabolite assessment will be obtained on Days 1 to 27.
Part 3 (Lemborexant plus Fluconazole): Mean AUC(0-24h) of lemborexant and metabolites
Day 1 at predose and at approximately 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 12 hours postdose. At approximately 24 (Day 2) hours after the first dose. Day 15 at predose and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 12 hours after the second dose. At approximately 24 (Day 16) hours after the second dose.
Measured: Blood samples for lemborexant and metabolite assessment will be obtained on Days 1 to 16.
Part 3 (Lemborexant plus Fluconazole): Mean AUC(0-72h) of lemborexant and metabolites
Day 1 at predose and at approximately 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 12 hours postdose. At approximately 24, 48, and 72 (Days 2 to 4) hours after the first dose. Day 15 at predose and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 12 hours after the second dose. At approximately 24, 48, 72 hours (Days 16 to 18 after the second dose).
Measured: Blood samples for lemborexant and metabolite assessment will be obtained on Days 1 to 18.
Part 3 (Lemborexant plus Fluconazole): Mean AUC(0-t) of lemborexant and metabolites
Day 1 at predose and at approximately 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 12 hours postdose. At approximately 24, 48, and 72 (Days 2 to 4); 120 (Day 6); 168 (Day 8); 216 (Day 10) hours after the first dose. Day 15 at predose and at approximately 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 12 hours after the second dose. At approximately 24, 48, and 72 (Days 16 to 18); 120 (Day 20); 168 (Day 22); 216 (Day 24); 288 (Day 27) hours after the second dose.
Measured: Blood samples for lemborexant and metabolite assessment will be obtained on Days 1 to 27.
Part 3 (Lemborexant plus Fluconazole): Mean AUC(0-inf) of lemborexant and metabolites
Day 1 at predose and at approximately 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 12 hours postdose. At approximately 24, 48, and 72 (Days 2 to 4); 120 (Day 6); 168 (Day 8); 216 (Day 10) hours after the first dose. Day 15 at predose and at approximately 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 12 hours after the second dose. At approximately 24, 48, and 72 (Days 16 to 18); 120 (Day 20); 168 (Day 22); 216 (Day 24); 288 (Day 27) hours after the second dose.
Measured: Blood samples for lemborexant and metabolite assessment will be obtained on Days 1 to 27.
Part 3 (Lemborexant plus Fluconazole): Mean t1/2 of lemborexant and metabolites following last dose
Day 1 at predose and at approximately 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 12 hours postdose. At approximately 24, 48, and 72 (Days 2 to 4); 120 (Day 6); 168 (Day 8); 216 (Day 10) hours after the first dose. Day 15 at predose and at approximately 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 12 hours after the second dose. At approximately 24, 48, and 72 (Days 16 to 18); 120 (Day 20); 168 (Day 22); 216 (Day 24); 288 (Day 27) hours after the second dose.
Measured: Blood samples for lemborexant and metabolite assessment will be obtained on Days 1 to 27.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2018
- Study start5 Feb 2018
- Primary completion23 Mar 2018
- Study completion23 Mar 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy SubjectsStudies of the same condition, open and under way.
- More trials run by Eisai Inc.The 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eisai Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Purdue Pharma LP
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03451110
- Sponsor's protocol ID
- E2006-A001-012
- Status last verified
- Feb 2018
- First submitted
- 23 Feb 2018
- Last updated
- 6 Sep 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 6 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A 3-Part, Open-label Study to Assess the Pharmacokinetic Drug-Drug Interactions of Lemborexant When Coadministered With an Oral Contraceptive, Famotidine, or Fluconazole in Healthy Subjects
- ClinicalTrials.gov ID
- NCT03451110
- Acronym / sponsor ID
- E2006-A001-012
- Conditions
- Healthy Subjects
- Keywords
- Drug-Drug Interactions, Lemborexant, Oral Contraceptive, Famotidine, Fluconazole, Pharmacokinetics, Proton pump inhibitors, CYP3A inhibitors
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Eisai Inc.Industry (pharma, biotech, devices)
- Collaborators
- Purdue Pharma LP
- Study start
- 5 Feb 2018 (actual)
- Primary completion
- 23 Mar 2018 (actual)
- Study completion
- 23 Mar 2018 (actual)
- First posted
- 1 Mar 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.
This study will be conducted to evaluate the effect of lemborexant 10 milligrams (mg) (at steady state) on the pharmacokinetics (PK) of a single-dose combined oral contraceptive, Loestrin 1.5/30 (containing 0.030 mg of ethinyl estradiol and 1.5 mg of norethindrone), and to evaluate the effect of fluconazole 200 mg (at steady state) and a single dose of famotidine 40 mg (an H2 blocker) on the PK of a single oral dose of lemborexant 10 mg.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Part 1: Lemborexant plus Loestrin | Experimental | Drug: lemborexant, Drug: LoestrinHealthy female participants will receive a single oral dose of Loestrin 1.5/30 (containing ethinyl estradiol [EE] 0.030 milligrams [mg] and norethindrone [NE] 1.5 mg) in the evening of Day 1 after a fast of at least 3 hours. After a washout period of at least 4 days, participants will receive 10 mg lemborexant orally for 10 days. Lemborexant will continue to be administered in the evening on Days 15 through 18, followed by a single oral dose of Loestrin on Day 15 when administered with lemborexant after fasting in the evening for at least 3 hours. |
| Part 2: Lemborexant plus Famotidine | Experimental | Drug: lemborexant, Drug: famotidineHealthy participants will receive a single oral dose of 10 mg lemborexant in the morning of Day 1 after an overnight fast of at least 10 hours. On Day 15, participants will receive a single oral dose of 40 mg famotidine, followed at least 2 hours later by a single dose of 10 mg lemborexant. After a washout period of up to 14 days participants will receive 10 mg lemborexant orally for 10 days. |
| Part 3: Lemborexant plus Fluconazole | Experimental | Drug: lemborexant, Drug: fluconazoleHealthy participants will receive a single oral dose of 10 mg lemborexant in the morning of Day 1 after an overnight fast of at least 10 hours. After a washout interval of approximately 10 days, on Day 11, participants will be administered 400 mg fluconazole followed by 200 mg fluconazole once daily from Days 12 to 26. During this time a single dose of 10 mg lemborexant will be administered following an overnight fast of at least 10 hours along with fluconazole on Day 15 only. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- Inclusion Criteria for All Participants (Part 1 - Oral Contraceptive; Part 2 - Famotidine; Part 3 - Fluconazole)
- Participants who meet all of the following inclusion criteria will be eligible for participation in the study:
- Body mass index >18 and ≤32 kilograms per meters squared at Screening
- Are willing and able to comply with all aspects of the protocol
- Provide written informed consent
Key exclusion criteria (24 listed)
- Known contraindication to Loestrin (only for Part 1), to Famotidine (only for Part 2), or to Fluconazole (only for Part 3)
- Females who are breastfeeding or pregnant at Screening or Baseline.
- Females of childbearing potential. NOTE: All females will be considered to be of childbearing potential unless they are postmenopausal (amenorrheic for at least 12 consecutive months, in the appropriate age group, and without other known or suspected cause) or have been sterilized surgically (i.e., bilateral tubal ligation, total hysterectomy, or bilateral oophorectomy, all with surgery at least 1 month before dosing).
- Clinically significant illness that requires medical treatment within 8 weeks or a clinically significant infection that requires medical treatment within 4 weeks of dosing
- Presence of significant illness that requires treatment or may influence the study assessments (e.g. psychiatric disorders, disorders of the gastrointestinal tract, liver, kidney, respiratory system, endocrine system, hematological system, neurological system, cardiovascular system, or a congenital abnormality)
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 |
|---|---|---|
| lemborexantAlso: E2006oral tablet | Drug | Part 1: Lemborexant plus Loestrin, Part 2: Lemborexant plus Famotidine, Part 3: Lemborexant plus Fluconazole |
| Loestrinoral tablet | Drug | Part 1: Lemborexant plus Loestrin |
| famotidineoral tablet | Drug | Part 2: Lemborexant plus Famotidine |
| fluconazoleoral tablet | Drug | Part 3: Lemborexant plus Fluconazole |
Primary outcome
Part 1 (Lemborexant plus Loestrin): Mean maximum observed concentration (Cmax) of lemborexant and metabolites
Time frame: Blood samples for lemborexant and metabolite assessment will be obtained at predose and 0.5 (30 minutes), 1, 1.5, 2, 3, 4, 5, 6, 8, 12, and 24 hours postdose on Days 14 and 15.
Part 1 (Lemborexant plus Loestrin): Mean predose drug concentration (Cmin) of lemborexant and metabolites
Time frame: Blood samples for lemborexant and metabolite assessment will be obtained at predose and 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, and 24 hours postdose on Days 14 and 15.
Part 1 (Lemborexant plus Loestrin): Mean time to reach maximum (peak) drug concentration following drug administration (Tmax) of lemborexant and metabolites
Time frame: Blood samples for lemborexant and metabolite assessment will be obtained at predose and 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, and 24 hours postdose on Days 14 and 15.
Part 1 (Lemborexant plus Loestrin): Mean area under the concentration-time curve from zero time to 24 hours postdose (AUC[0-24h]) of lemborexant and metabolites
Time frame: Blood samples for lemborexant and metabolite assessment will be obtained at predose and 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, and 24 hours postdose on Days 14 and 15.
Part 2 (Lemborexant plus Famotidine): Mean Cmax of lemborexant and metabolites
Time frame: Blood samples for lemborexant and metabolite assessment will be obtained at predose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72, 120, 168, and 216 hours after dosing on Days 1 and 15.
Part 2 (Lemborexant plus Famotidine): Mean Tmax of lemborexant and metabolites
Time frame: Blood samples for lemborexant and metabolite assessment will be obtained at predose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72, 120, 168, and 216 hours after dosing on Days 1 and 15.
Part 2 (Lemborexant plus Famotidine): Mean AUC(0-24h) of lemborexant and metabolites
Time frame: Blood samples for lemborexant and metabolite assessment will be obtained at predose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72, 120, 168, and 216 hours after dosing on Days 1 and 15.
Part 2 (Lemborexant plus Famotidine): Mean AUC from zero time to 72 hours postdose (AUC[0-72h]) of lemborexant and metabolites
Time frame: Blood samples for lemborexant and metabolite assessment will be obtained at predose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72, 120, 168, and 216 hours after dosing on Days 1 and 15.
Part 2 (Lemborexant plus Famotidine): Mean AUC from zero time to last measurable time (AUC[0-t]) of lemborexant and metabolites
Time frame: Blood samples for lemborexant and metabolite assessment will be obtained at predose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72, 120, 168, and 216 hours after dosing on Days 1 and 15.
Part 2 (Lemborexant plus Famotidine): Mean AUC from zero time extrapolated to infinite time (AUC[0-inf]) of lemborexant and metabolites
Time frame: Blood samples for lemborexant and metabolite assessment will be obtained at predose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72, 120, 168, and 216 hours after dosing on Days 1 and 15.
Part 2 (Lemborexant plus Famotidine): Mean terminal elimination half-life (t1/2) of lemborexant and metabolites following the last dose
Time frame: Blood samples for lemborexant and metabolite assessment will be obtained at predose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72, 120, 168, and 216 hours after dosing on Days 1 and 15.
Part 3 (Lemborexant plus Fluconazole): Mean Cmax of lemborexant and metabolites
Time frame: Blood samples for lemborexant and metabolite assessment will be obtained on Days 1 to 27.
Day 1 at predose and at approximately 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 12 hours postdose. At approximately 24, 48, and 72 (Days 2 to 4); 120 (Day 6); 168 (Day 8); 216 (Day 10) hours after the first dose. Day 15 at predose and at approximately 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 12 hours after the second dose. At approximately 24, 48, and 72 (Days 16 to 18); 120 (Day 20); 168 (Day 22); 216 (Day 24); 288 (Day 27) hours after the second dose.
Part 3 (Lemborexant plus Fluconazole): Mean Tmax of lemborexant and metabolites
Time frame: Blood samples for lemborexant and metabolite assessment will be obtained on Days 1 to 27.
Day 1 at predose and at approximately 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 12 hours postdose. At approximately 24, 48, and 72 (Days 2 to 4); 120 (Day 6); 168 (Day 8); 216 (Day 10) hours after the first dose. Day 15 at predose and at approximately 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 12 hours after the second dose. At approximately 24, 48, and 72 (Days 16 to 18); 120 (Day 20); 168 (Day 22); 216 (Day 24); 288 (Day 27) hours after the second dose.
Part 3 (Lemborexant plus Fluconazole): Mean AUC(0-24h) of lemborexant and metabolites
Time frame: Blood samples for lemborexant and metabolite assessment will be obtained on Days 1 to 16.
Day 1 at predose and at approximately 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 12 hours postdose. At approximately 24 (Day 2) hours after the first dose. Day 15 at predose and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 12 hours after the second dose. At approximately 24 (Day 16) hours after the second dose.
Part 3 (Lemborexant plus Fluconazole): Mean AUC(0-72h) of lemborexant and metabolites
Time frame: Blood samples for lemborexant and metabolite assessment will be obtained on Days 1 to 18.
Day 1 at predose and at approximately 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 12 hours postdose. At approximately 24, 48, and 72 (Days 2 to 4) hours after the first dose. Day 15 at predose and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 12 hours after the second dose. At approximately 24, 48, 72 hours (Days 16 to 18 after the second dose).
Part 3 (Lemborexant plus Fluconazole): Mean AUC(0-t) of lemborexant and metabolites
Time frame: Blood samples for lemborexant and metabolite assessment will be obtained on Days 1 to 27.
Day 1 at predose and at approximately 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 12 hours postdose. At approximately 24, 48, and 72 (Days 2 to 4); 120 (Day 6); 168 (Day 8); 216 (Day 10) hours after the first dose. Day 15 at predose and at approximately 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 12 hours after the second dose. At approximately 24, 48, and 72 (Days 16 to 18); 120 (Day 20); 168 (Day 22); 216 (Day 24); 288 (Day 27) hours after the second dose.
Part 3 (Lemborexant plus Fluconazole): Mean AUC(0-inf) of lemborexant and metabolites
Time frame: Blood samples for lemborexant and metabolite assessment will be obtained on Days 1 to 27.
Day 1 at predose and at approximately 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 12 hours postdose. At approximately 24, 48, and 72 (Days 2 to 4); 120 (Day 6); 168 (Day 8); 216 (Day 10) hours after the first dose. Day 15 at predose and at approximately 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 12 hours after the second dose. At approximately 24, 48, and 72 (Days 16 to 18); 120 (Day 20); 168 (Day 22); 216 (Day 24); 288 (Day 27) hours after the second dose.
Part 3 (Lemborexant plus Fluconazole): Mean t1/2 of lemborexant and metabolites following last dose
Time frame: Blood samples for lemborexant and metabolite assessment will be obtained on Days 1 to 27.
Day 1 at predose and at approximately 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 12 hours postdose. At approximately 24, 48, and 72 (Days 2 to 4); 120 (Day 6); 168 (Day 8); 216 (Day 10) hours after the first dose. Day 15 at predose and at approximately 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 12 hours after the second dose. At approximately 24, 48, and 72 (Days 16 to 18); 120 (Day 20); 168 (Day 22); 216 (Day 24); 288 (Day 27) hours after the second dose.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Sep 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.
The record lists no contact. Use the official record to reach the sponsor.
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 lemborexant, Loestrin and famotidine in people with Healthy Subjects, run by Eisai Inc. at 1 site in United States.
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 10 inclusion and 24 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: finished, as of the sponsor's last update on 6 Sep 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 United States. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Part 1 (Lemborexant plus Loestrin): Mean maximum observed concentration (Cmax) of lemborexant and metabolites (time frame: Blood samples for lemborexant and metabolite assessment will be obtained at predose and 0.5 (30 minutes), 1, 1.5, 2, 3, 4, 5, 6, 8, 12, and 24 hours postdose on Days 14 and 15.). The study lists 18 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 6 Sep 2018.