Healthy ParticipantsPhase 1NCT03082235
Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of E6742 in Healthy Adult Subjects
A Phase 1 study testing E6742 in people with Healthy Participants, run by Eisai Inc. at 1 site in United States.
Trial summary
Study E6742-A001-001 is a randomized, double-blind, placebo-controlled, single ascending dose study conducted to evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of single ascending oral doses of E6742 in healthy adult participants. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Participants
- What is being tested?
- E6742
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 72 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Mar 2017to 11 Oct 2017
- 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 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Nonsmoking, male or female, age ≥18 years and ≤45 years old at the time of informed consent
- Body mass index (BMI) ≥18 and <32 kilograms per meters squared (kg/m2) at Screening
Who cannot join
- Females who are breastfeeding or pregnant at Screening or Baseline (as documented by a positive beta-human chorionic gonadotropin [β-hCG] or human chorionic gonadotropin [hCG] test with a minimum sensitivity of 25 International Units per Liter [IU/L] or equivalent units of β-hCG [or hCG]). A separate baseline assessment is required if a negative screening pregnancy test was obtained more than 72 hours before the first dose of study drug.
- Males who have not had a successful vasectomy (confirmed azoospermia) or they and their female partners do not meet the criteria above (ie, not of childbearing potential or practicing highly effective contraception throughout the study period and for 5 times the half-life of the study drug plus 90 days after study drug discontinuation). No sperm donation is allowed during the study period and for 5 times the half-life of the study drug plus 90 days after study drug discontinuation.
- Any history of gastrointestinal surgery that may affect pharmacokinetic (PK) profiles of E6742 (eg, hepatectomy, nephrectomy, digestive organ resection) at Screening
- A prolonged QTcF interval (QTcF >450 ms) demonstrated on ECG at Screening or Baseline
- Persistent systolic blood pressure >130 mmHg or diastolic blood pressure >85 mmHg diastolic at Screening or Baseline Heart rate less than 50 or more than 100 beats/min at Screening or Baseline
- Known history of prolonged QT/QTc interval
Show all 19Show fewer
- Left bundle branch block
- Known history of myocardial infarction or active ischemic heart disease
- Known history of clinically significant arrhythmia or uncontrolled arrhythmia
- Known history of clinically significant drug allergy at Screening
- Known history of food allergies or presently experiencing significant seasonal or perennial allergy at Screening
- Known to be human immunodeficiency virus (HIV) positive at Screening
- Active viral hepatitis (A, B, or C) as demonstrated by positive serology at Screening
- History of drug or alcohol dependency or abuse within the 2 years prior to Screening, or those who have a positive urine drug and alcohol test at Screening or Baseline
- Intake of herbal preparations containing St. John's Wort within 4 weeks before dosing
- Use of prescription drugs within 4 weeks before dosing
- Intake of over-the-counter (OTC) medications within 2 weeks before dosing
- Currently enrolled in another clinical study or used any investigational drug or device within 30 days (or 5 half-lives, whichever is longer) before informed consent
- Receipt of blood products within 4 weeks, or donation of blood within 8 weeks, or donation of plasma within 1 week before dosing
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Double-Blind, Placebo-Controlled, Single Ascending Dose Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of E6742 in Healthy Adult Subjects
Study E6742-A001-001 is a randomized, double-blind, placebo-controlled, single ascending dose study conducted to evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of single ascending oral doses of E6742 in healthy adult participants.
- Conditions
- Healthy Participants
- Being tested
- E6742, Placebo
- Keywords
- Healthy participants, E6742, pharmacokinetics
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
E6742Drug
gelatin capsules
PlaceboDrug
gelatin capsules
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1: 10 mg E6742 | Experimental | Participants will receive 10 milligrams (mg) E6742 as a single oral dose in the fasted state. Receives: Drug: E6742 |
| Cohort 1: Matching placebo | Placebo comparator | Participants will receive a single oral dose of placebo matching E6742 in the fasted state. Receives: Drug: Placebo |
| Cohort 2: 25 mg E6742 | Experimental | Participants will receive 25 mg E6742 as a single oral dose in the fasted state. Receives: Drug: E6742 |
| Cohort 2: Matching placebo | Placebo comparator | Participants will receive a single oral dose of placebo matching E6742 in the fasted state. Receives: Drug: Placebo |
| Cohort 3: 50 mg E6742 | Experimental | Participants will receive 50 mg E6742 as a single oral dose in the fasted state. Receives: Drug: E6742 |
| Cohort 3: Matching placebo | Placebo comparator | Participants will receive a single oral dose of placebo matching E6742 in the fasted state. Receives: Drug: Placebo |
| Cohort 4: 100 mg E6742 | Experimental | Participants will receive 100 mg E6742 as a single oral dose in the fasted state. Participants will then receive the same single oral dose of E6742 again in the fed state after a washout interval (at least 7 days or 5 half-lives of E6742, whichever is longer) for the evaluation of food effect. Receives: Drug: E6742 |
| Cohort 4: Matching placebo | Placebo comparator | Participants will receive a single oral dose of placebo matching E6742 in the fasted state. Participants will then receive the same single oral dose of placebo again in the fed state after a washout interval (at least 7 days ) for the evaluation of food effect. Receives: Drug: Placebo |
| Cohort 5: 200 mg E6742 | Experimental | Participants will receive 200 mg E6742 as a single oral dose in the fasted state. Receives: Drug: E6742 |
| Cohort 5: Matching placebo | Placebo comparator | Participants will receive a single oral dose of placebo matching E6742 in the fasted state. Receives: Drug: Placebo |
| Cohort 6: 400 mg E6742 | Experimental | Participants will receive 400 mg E6742 as a single oral dose in the fasted state. Receives: Drug: E6742 |
| Cohort 6: Matching placebo | Placebo comparator | Participants will receive a single oral dose of placebo matching E6742 in the fasted state. Receives: Drug: Placebo |
| Cohort 7: 800 mg E6742 | Experimental | Participants will receive 800 mg E6742 as a single oral dose in the fasted state. Receives: Drug: E6742 |
| Cohort 7: Matching placebo | Placebo comparator | Participants will receive a single oral dose of placebo matching E6742 in the fasted state. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with any serious adverse event and number of participants with any non-serious adverse event
The number of participants with any serious adverse event and the number of participants with any non-serious adverse event will be reported.
Measured: from Screening up to Day 7
Mean maximum observed concentration (Cmax) of E6742 and the metabolite ER-1132963 in plasma
Cohorts 1, 2, 3, 5, and 6: Day 1 at predose and 0.5 (30 minutes), 1, 2, 3, 4, 6, 8, 10, and 12 hours postdose; Day 2 (24 and 36 hours postdose); Day 3 (48 hours postdose); Day 4 (72 hours postdose); Day 5 (96 hours postdose); Day 6 (120 hours postdose); Day 7 (144 hours postdose). Cohort 4: In both periods (Treatment Periods 1 [7 days] and 2 [6 days]), Day 1 at predose and 0.5 (30 minutes), 1, 2, 3, 4, 6, 8, 10, and 12 hours postdose; Day 2 (24 and 36 hours postdose); Day 3 (48 hours postdose); Day 4 (72 hours postdose); Day 5 (96 hours postdose); Day 6 (120 hours postdose); Day 7 (144 hours postdose).
Measured: Days 1 to 7
Time at which the highest drug concentration occurs (tmax) for E6742 and the metabolite ER-1132963 in plasma
Cohorts 1, 2, 3, 5, and 6: Day 1 at predose and 0.5 (30 minutes), 1, 2, 3, 4, 6, 8, 10, and 12 hours postdose; Day 2 (24 and 36 hours postdose); Day 3 (48 hours postdose); Day 4 (72 hours postdose); Day 5 (96 hours postdose); Day 6 (120 hours postdose); Day 7 (144 hours postdose). Cohort 4: In both periods (Treatment Periods 1 [7 days] and 2 [6 days]), Day 1 at predose and 0.5 (30 minutes), 1, 2, 3, 4, 6, 8, 10, and 12 hours postdose; Day 2 (24 and 36 hours postdose); Day 3 (48 hours postdose); Day 4 (72 hours postdose); Day 5 (96 hours postdose); Day 6 (120 hours postdose); Day 7 (144 hours postdose).
Measured: Days 1 to 7
Area under the concentration-time curve from zero time to 24 hours postdose (AUC[0-24h]) E6742 and the metabolite ER-1132963 in plasma
Cohorts 1, 2, 3, 5, and 6: Day 1 at predose and 0.5 (30 minutes), 1, 2, 3, 4, 6, 8, 10, and 12 hours postdose; Day 2 (24 and 36 hours postdose); Day 3 (48 hours postdose); Day 4 (72 hours postdose); Day 5 (96 hours postdose); Day 6 (120 hours postdose); Day 7 (144 hours postdose). Cohort 4: In both periods (Treatment Periods 1 [7 days] and 2 [6 days]), Day 1 at predose and 0.5 (30 minutes), 1, 2, 3, 4, 6, 8, 10, and 12 hours postdose; Day 2 (24 and 36 hours postdose); Day 3 (48 hours postdose); Day 4 (72 hours postdose); Day 5 (96 hours postdose); Day 6 (120 hours postdose); Day 7 (144 hours postdose).
Measured: Days 1 to 7
Area under the concentration-time curve from zero time to 72 hours postdose (AUC[0-72h]) for E6742 and the metabolite ER-1132963 in plasma
Cohorts 1, 2, 3, 5, and 6: Day 1 at predose and 0.5 (30 minutes), 1, 2, 3, 4, 6, 8, 10, and 12 hours postdose; Day 2 (24 and 36 hours postdose); Day 3 (48 hours postdose); Day 4 (72 hours postdose); Day 5 (96 hours postdose); Day 6 (120 hours postdose); Day 7 (144 hours postdose). Cohort 4: In both periods (Treatment Periods 1 [7 days] and 2 [6 days]), Day 1 at predose and 0.5 (30 minutes), 1, 2, 3, 4, 6, 8, 10, and 12 hours postdose; Day 2 (24 and 36 hours postdose); Day 3 (48 hours postdose); Day 4 (72 hours postdose); Day 5 (96 hours postdose); Day 6 (120 hours postdose); Day 7 (144 hours postdose).
Measured: Days 1 to 7
Area under the concentration-time curve from zero time to time of last quantifiable concentration (AUC[0-t]) for E6742 and the metabolite ER-1132963 in plasma
Cohorts 1, 2, 3, 5, and 6: Day 1 at predose and 0.5 (30 minutes), 1, 2, 3, 4, 6, 8, 10, and 12 hours postdose; Day 2 (24 and 36 hours postdose); Day 3 (48 hours postdose); Day 4 (72 hours postdose); Day 5 (96 hours postdose); Day 6 (120 hours postdose); Day 7 (144 hours postdose). Cohort 4: In both periods (Treatment Periods 1 [7 days] and 2 [6 days]), Day 1 at predose and 0.5 (30 minutes), 1, 2, 3, 4, 6, 8, 10, and 12 hours postdose; Day 2 (24 and 36 hours postdose); Day 3 (48 hours postdose); Day 4 (72 hours postdose); Day 5 (96 hours postdose); Day 6 (120 hours postdose); Day 7 (144 hours postdose).
Measured: Days 1 to 7
Area under the concentration-time curve from zero time extrapolated to infinite time (AUC[0-inf]) for E6742 and the metabolite ER-1132963 in plasma
Cohorts 1, 2, 3, 5, and 6: Day 1 at predose and 0.5 (30 minutes), 1, 2, 3, 4, 6, 8, 10, and 12 hours postdose; Day 2 (24 and 36 hours postdose); Day 3 (48 hours postdose); Day 4 (72 hours postdose); Day 5 (96 hours postdose); Day 6 (120 hours postdose); Day 7 (144 hours postdose). Cohort 4: In both periods (Treatment Periods 1 [7 days] and 2 [6 days]), Day 1 at predose and 0.5 (30 minutes), 1, 2, 3, 4, 6, 8, 10, and 12 hours postdose; Day 2 (24 and 36 hours postdose); Day 3 (48 hours postdose); Day 4 (72 hours postdose); Day 5 (96 hours postdose); Day 6 (120 hours postdose); Day 7 (144 hours postdose).
Measured: Days 1 to 7
Terminal elimination phase half-life (t1/2) for E6742 and the metabolite ER-1132963 in plasma
Cohorts 1, 2, 3, 5, and 6: Day 1 at predose and 0.5 (30 minutes), 1, 2, 3, 4, 6, 8, 10, and 12 hours postdose; Day 2 (24 and 36 hours postdose); Day 3 (48 hours postdose); Day 4 (72 hours postdose); Day 5 (96 hours postdose); Day 6 (120 hours postdose); Day 7 (144 hours postdose). Cohort 4: In both periods (Treatment Periods 1 [7 days] and 2 [6 days]), Day 1 at predose and 0.5 (30 minutes), 1, 2, 3, 4, 6, 8, 10, and 12 hours postdose; Day 2 (24 and 36 hours postdose); Day 3 (48 hours postdose); Day 4 (72 hours postdose); Day 5 (96 hours postdose); Day 6 (120 hours postdose); Day 7 (144 hours postdose).
Measured: Days 1 to 7
Apparent total clearance following extravascular administration (CL/F) for E6742 in plasma
Cohorts 1, 2, 3, 5, and 6: Day 1 at predose and 0.5 (30 minutes), 1, 2, 3, 4, 6, 8, 10, and 12 hours postdose; Day 2 (24 and 36 hours postdose); Day 3 (48 hours postdose); Day 4 (72 hours postdose); Day 5 (96 hours postdose); Day 6 (120 hours postdose); Day 7 (144 hours postdose). Cohort 4: In both periods (Treatment Periods 1 [7 days] and 2 [6 days]), Day 1 at predose and 0.5 (30 minutes), 1, 2, 3, 4, 6, 8, 10, and 12 hours postdose; Day 2 (24 and 36 hours postdose); Day 3 (48 hours postdose); Day 4 (72 hours postdose); Day 5 (96 hours postdose); Day 6 (120 hours postdose); Day 7 (144 hours postdose).
Measured: Days 1 to 7
Apparent volume of distribution at terminal phase (Vz/F) for E6742 in plasma
Cohorts 1, 2, 3, 5, and 6: Day 1 at predose and 0.5 (30 minutes), 1, 2, 3, 4, 6, 8, 10, and 12 hours postdose; Day 2 (24 and 36 hours postdose); Day 3 (48 hours postdose); Day 4 (72 hours postdose); Day 5 (96 hours postdose); Day 6 (120 hours postdose); Day 7 (144 hours postdose). Cohort 4: In both periods (Treatment Periods 1 [7 days] and 2 [6 days]), Day 1 at predose and 0.5 (30 minutes), 1, 2, 3, 4, 6, 8, 10, and 12 hours postdose; Day 2 (24 and 36 hours postdose); Day 3 (48 hours postdose); Day 4 (72 hours postdose); Day 5 (96 hours postdose); Day 6 (120 hours postdose); Day 7 (144 hours postdose).
Measured: Days 1 to 7
AUC metabolite to E6742 ratio following molecular weight correction to E6742 equivalents in plasma
Cohorts 1, 2, 3, 5, and 6: Day 1 at predose and 0.5 (30 minutes), 1, 2, 3, 4, 6, 8, 10, and 12 hours postdose; Day 2 (24 and 36 hours postdose); Day 3 (48 hours postdose); Day 4 (72 hours postdose); Day 5 (96 hours postdose); Day 6 (120 hours postdose); Day 7 (144 hours postdose). Cohort 4: In both periods (Treatment Periods 1 [7 days] and 2 [6 days]), Day 1 at predose and 0.5 (30 minutes), 1, 2, 3, 4, 6, 8, 10, and 12 hours postdose; Day 2 (24 and 36 hours postdose); Day 3 (48 hours postdose); Day 4 (72 hours postdose); Day 5 (96 hours postdose); Day 6 (120 hours postdose); Day 7 (144 hours postdose).
Measured: Days 1 to 7
Amount of unchanged drug excreted in urine (Ae) for E6742 and the metabolite ER-1132963
Cohorts 1, 2, 3, 5, and 6: Days 1 to 7: predose and 0 to 4, >4 to 8, >8 to 12, >12 to 24, >24 to 48, >48 to 72, >72 to 96, >96 to 120, and >120 to 144 hours postdose. Cohort 4: Days 1 to 7 (Treatment Period 1): predose and 0 to 4, >4 to 8, >8 to 12, >12 to 24, >24 to 48, >48 to 72, >72 to 96, >96 to 120, and >120 to 144 hours postdose.
Measured: Days 1 to 7
Renal clearance (CLR)
Cohorts 1, 2, 3, 5, and 6: Days 1 to 7: predose and 0 to 4, >4 to 8, >8 to 12, >12 to 24, >24 to 48, >48 to 72, >72 to 96, >96 to 120, and >120 to 144 hours postdose. Cohort 4: Days 1 to 7 (Treatment Period 1): predose and 0 to 4, >4 to 8, >8 to 12, >12 to 24, >24 to 48, >48 to 72, >72 to 96, >96 to 120, and >120 to 144 hours postdose.
Measured: Days 1 to 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2017
- Study start3 Mar 2017
- Primary completion11 Oct 2017
- Study completion11 Oct 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy ParticipantsStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eisai Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03082235
- Sponsor's protocol ID
- E6742-A001-001
- Status last verified
- Nov 2017
- First submitted
- 14 Mar 2017
- Last updated
- 7 Sep 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Placebo-Controlled, Single Ascending Dose Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of E6742 in Healthy Adult Subjects
- ClinicalTrials.gov ID
- NCT03082235
- Acronym / sponsor ID
- E6742-A001-001
- Conditions
- Healthy Participants
- Keywords
- Healthy participants, E6742, pharmacokinetics
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- Eisai Inc.Industry (pharma, biotech, devices)
- Study start
- 3 Mar 2017 (actual)
- Primary completion
- 11 Oct 2017 (actual)
- Study completion
- 11 Oct 2017 (actual)
- First posted
- 17 Mar 2017 (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.
Study E6742-A001-001 is a randomized, double-blind, placebo-controlled, single ascending dose study conducted to evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of single ascending oral doses of E6742 in healthy adult participants.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 14
| Arm | Type | Receives |
|---|---|---|
| Cohort 1: 10 mg E6742 | Experimental | Drug: E6742Participants will receive 10 milligrams (mg) E6742 as a single oral dose in the fasted state. |
| Cohort 1: Matching placebo | Placebo comparator | Drug: PlaceboParticipants will receive a single oral dose of placebo matching E6742 in the fasted state. |
| Cohort 2: 25 mg E6742 | Experimental | Drug: E6742Participants will receive 25 mg E6742 as a single oral dose in the fasted state. |
| Cohort 2: Matching placebo | Placebo comparator | Drug: PlaceboParticipants will receive a single oral dose of placebo matching E6742 in the fasted state. |
| Cohort 3: 50 mg E6742 | Experimental | Drug: E6742Participants will receive 50 mg E6742 as a single oral dose in the fasted state. |
| Cohort 3: Matching placebo | Placebo comparator | Drug: PlaceboParticipants will receive a single oral dose of placebo matching E6742 in the fasted state. |
| Cohort 4: 100 mg E6742 | Experimental | Drug: E6742Participants will receive 100 mg E6742 as a single oral dose in the fasted state. Participants will then receive the same single oral dose of E6742 again in the fed state after a washout interval (at least 7 days or 5 half-lives of E6742, whichever is longer) for the evaluation of food effect. |
| Cohort 4: Matching placebo | Placebo comparator | Drug: PlaceboParticipants will receive a single oral dose of placebo matching E6742 in the fasted state. Participants will then receive the same single oral dose of placebo again in the fed state after a washout interval (at least 7 days ) for the evaluation of food effect. |
| Cohort 5: 200 mg E6742 | Experimental | Drug: E6742Participants will receive 200 mg E6742 as a single oral dose in the fasted state. |
| Cohort 5: Matching placebo | Placebo comparator | Drug: PlaceboParticipants will receive a single oral dose of placebo matching E6742 in the fasted state. |
| Cohort 6: 400 mg E6742 | Experimental | Drug: E6742Participants will receive 400 mg E6742 as a single oral dose in the fasted state. |
| Cohort 6: Matching placebo | Placebo comparator | Drug: PlaceboParticipants will receive a single oral dose of placebo matching E6742 in the fasted state. |
| Cohort 7: 800 mg E6742 | Experimental | Drug: E6742Participants will receive 800 mg E6742 as a single oral dose in the fasted state. |
| Cohort 7: Matching placebo | Placebo comparator | Drug: PlaceboParticipants will receive a single oral dose of placebo matching E6742 in the fasted state. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Nonsmoking, male or female, age ≥18 years and ≤45 years old at the time of informed consent
- Body mass index (BMI) ≥18 and <32 kilograms per meters squared (kg/m2) at Screening
Key exclusion criteria (19 listed)
- Females who are breastfeeding or pregnant at Screening or Baseline (as documented by a positive beta-human chorionic gonadotropin [β-hCG] or human chorionic gonadotropin [hCG] test with a minimum sensitivity of 25 International Units per Liter [IU/L] or equivalent units of β-hCG [or hCG]). A separate baseline assessment is required if a negative screening pregnancy test was obtained more than 72 hours before the first dose of study drug.
- Males who have not had a successful vasectomy (confirmed azoospermia) or they and their female partners do not meet the criteria above (ie, not of childbearing potential or practicing highly effective contraception throughout the study period and for 5 times the half-life of the study drug plus 90 days after study drug discontinuation). No sperm donation is allowed during the study period and for 5 times the half-life of the study drug plus 90 days after study drug discontinuation.
- Any history of gastrointestinal surgery that may affect pharmacokinetic (PK) profiles of E6742 (eg, hepatectomy, nephrectomy, digestive organ resection) at Screening
- A prolonged QTcF interval (QTcF >450 ms) demonstrated on ECG at Screening or Baseline
- Persistent systolic blood pressure >130 mmHg or diastolic blood pressure >85 mmHg diastolic at Screening or Baseline Heart rate less than 50 or more than 100 beats/min at Screening or Baseline
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 |
|---|---|---|
| E6742gelatin capsules | Drug | Cohort 1: 10 mg E6742, Cohort 2: 25 mg E6742, Cohort 3: 50 mg E6742, Cohort 4: 100 mg E6742, Cohort 5: 200 mg E6742, Cohort 6: 400 mg E6742, Cohort 7: 800 mg E6742 |
| Placebogelatin capsules | Drug | Cohort 1: Matching placebo, Cohort 2: Matching placebo, Cohort 3: Matching placebo, Cohort 4: Matching placebo, Cohort 5: Matching placebo, Cohort 6: Matching placebo, Cohort 7: Matching placebo |
Primary outcome
Number of participants with any serious adverse event and number of participants with any non-serious adverse event
Time frame: from Screening up to Day 7
The number of participants with any serious adverse event and the number of participants with any non-serious adverse event will be reported.
Mean maximum observed concentration (Cmax) of E6742 and the metabolite ER-1132963 in plasma
Time frame: Days 1 to 7
Cohorts 1, 2, 3, 5, and 6: Day 1 at predose and 0.5 (30 minutes), 1, 2, 3, 4, 6, 8, 10, and 12 hours postdose; Day 2 (24 and 36 hours postdose); Day 3 (48 hours postdose); Day 4 (72 hours postdose); Day 5 (96 hours postdose); Day 6 (120 hours postdose); Day 7 (144 hours postdose). Cohort 4: In both periods (Treatment Periods 1 [7 days] and 2 [6 days]), Day 1 at predose and 0.5 (30 minutes), 1, 2, 3, 4, 6, 8, 10, and 12 hours postdose; Day 2 (24 and 36 hours postdose); Day 3 (48 hours postdose); Day 4 (72 hours postdose); Day 5 (96 hours postdose); Day 6 (120 hours postdose); Day 7 (144 hours postdose).
Time at which the highest drug concentration occurs (tmax) for E6742 and the metabolite ER-1132963 in plasma
Time frame: Days 1 to 7
Cohorts 1, 2, 3, 5, and 6: Day 1 at predose and 0.5 (30 minutes), 1, 2, 3, 4, 6, 8, 10, and 12 hours postdose; Day 2 (24 and 36 hours postdose); Day 3 (48 hours postdose); Day 4 (72 hours postdose); Day 5 (96 hours postdose); Day 6 (120 hours postdose); Day 7 (144 hours postdose). Cohort 4: In both periods (Treatment Periods 1 [7 days] and 2 [6 days]), Day 1 at predose and 0.5 (30 minutes), 1, 2, 3, 4, 6, 8, 10, and 12 hours postdose; Day 2 (24 and 36 hours postdose); Day 3 (48 hours postdose); Day 4 (72 hours postdose); Day 5 (96 hours postdose); Day 6 (120 hours postdose); Day 7 (144 hours postdose).
Area under the concentration-time curve from zero time to 24 hours postdose (AUC[0-24h]) E6742 and the metabolite ER-1132963 in plasma
Time frame: Days 1 to 7
Cohorts 1, 2, 3, 5, and 6: Day 1 at predose and 0.5 (30 minutes), 1, 2, 3, 4, 6, 8, 10, and 12 hours postdose; Day 2 (24 and 36 hours postdose); Day 3 (48 hours postdose); Day 4 (72 hours postdose); Day 5 (96 hours postdose); Day 6 (120 hours postdose); Day 7 (144 hours postdose). Cohort 4: In both periods (Treatment Periods 1 [7 days] and 2 [6 days]), Day 1 at predose and 0.5 (30 minutes), 1, 2, 3, 4, 6, 8, 10, and 12 hours postdose; Day 2 (24 and 36 hours postdose); Day 3 (48 hours postdose); Day 4 (72 hours postdose); Day 5 (96 hours postdose); Day 6 (120 hours postdose); Day 7 (144 hours postdose).
Area under the concentration-time curve from zero time to 72 hours postdose (AUC[0-72h]) for E6742 and the metabolite ER-1132963 in plasma
Time frame: Days 1 to 7
Cohorts 1, 2, 3, 5, and 6: Day 1 at predose and 0.5 (30 minutes), 1, 2, 3, 4, 6, 8, 10, and 12 hours postdose; Day 2 (24 and 36 hours postdose); Day 3 (48 hours postdose); Day 4 (72 hours postdose); Day 5 (96 hours postdose); Day 6 (120 hours postdose); Day 7 (144 hours postdose). Cohort 4: In both periods (Treatment Periods 1 [7 days] and 2 [6 days]), Day 1 at predose and 0.5 (30 minutes), 1, 2, 3, 4, 6, 8, 10, and 12 hours postdose; Day 2 (24 and 36 hours postdose); Day 3 (48 hours postdose); Day 4 (72 hours postdose); Day 5 (96 hours postdose); Day 6 (120 hours postdose); Day 7 (144 hours postdose).
Area under the concentration-time curve from zero time to time of last quantifiable concentration (AUC[0-t]) for E6742 and the metabolite ER-1132963 in plasma
Time frame: Days 1 to 7
Cohorts 1, 2, 3, 5, and 6: Day 1 at predose and 0.5 (30 minutes), 1, 2, 3, 4, 6, 8, 10, and 12 hours postdose; Day 2 (24 and 36 hours postdose); Day 3 (48 hours postdose); Day 4 (72 hours postdose); Day 5 (96 hours postdose); Day 6 (120 hours postdose); Day 7 (144 hours postdose). Cohort 4: In both periods (Treatment Periods 1 [7 days] and 2 [6 days]), Day 1 at predose and 0.5 (30 minutes), 1, 2, 3, 4, 6, 8, 10, and 12 hours postdose; Day 2 (24 and 36 hours postdose); Day 3 (48 hours postdose); Day 4 (72 hours postdose); Day 5 (96 hours postdose); Day 6 (120 hours postdose); Day 7 (144 hours postdose).
Area under the concentration-time curve from zero time extrapolated to infinite time (AUC[0-inf]) for E6742 and the metabolite ER-1132963 in plasma
Time frame: Days 1 to 7
Cohorts 1, 2, 3, 5, and 6: Day 1 at predose and 0.5 (30 minutes), 1, 2, 3, 4, 6, 8, 10, and 12 hours postdose; Day 2 (24 and 36 hours postdose); Day 3 (48 hours postdose); Day 4 (72 hours postdose); Day 5 (96 hours postdose); Day 6 (120 hours postdose); Day 7 (144 hours postdose). Cohort 4: In both periods (Treatment Periods 1 [7 days] and 2 [6 days]), Day 1 at predose and 0.5 (30 minutes), 1, 2, 3, 4, 6, 8, 10, and 12 hours postdose; Day 2 (24 and 36 hours postdose); Day 3 (48 hours postdose); Day 4 (72 hours postdose); Day 5 (96 hours postdose); Day 6 (120 hours postdose); Day 7 (144 hours postdose).
Terminal elimination phase half-life (t1/2) for E6742 and the metabolite ER-1132963 in plasma
Time frame: Days 1 to 7
Cohorts 1, 2, 3, 5, and 6: Day 1 at predose and 0.5 (30 minutes), 1, 2, 3, 4, 6, 8, 10, and 12 hours postdose; Day 2 (24 and 36 hours postdose); Day 3 (48 hours postdose); Day 4 (72 hours postdose); Day 5 (96 hours postdose); Day 6 (120 hours postdose); Day 7 (144 hours postdose). Cohort 4: In both periods (Treatment Periods 1 [7 days] and 2 [6 days]), Day 1 at predose and 0.5 (30 minutes), 1, 2, 3, 4, 6, 8, 10, and 12 hours postdose; Day 2 (24 and 36 hours postdose); Day 3 (48 hours postdose); Day 4 (72 hours postdose); Day 5 (96 hours postdose); Day 6 (120 hours postdose); Day 7 (144 hours postdose).
Apparent total clearance following extravascular administration (CL/F) for E6742 in plasma
Time frame: Days 1 to 7
Cohorts 1, 2, 3, 5, and 6: Day 1 at predose and 0.5 (30 minutes), 1, 2, 3, 4, 6, 8, 10, and 12 hours postdose; Day 2 (24 and 36 hours postdose); Day 3 (48 hours postdose); Day 4 (72 hours postdose); Day 5 (96 hours postdose); Day 6 (120 hours postdose); Day 7 (144 hours postdose). Cohort 4: In both periods (Treatment Periods 1 [7 days] and 2 [6 days]), Day 1 at predose and 0.5 (30 minutes), 1, 2, 3, 4, 6, 8, 10, and 12 hours postdose; Day 2 (24 and 36 hours postdose); Day 3 (48 hours postdose); Day 4 (72 hours postdose); Day 5 (96 hours postdose); Day 6 (120 hours postdose); Day 7 (144 hours postdose).
Apparent volume of distribution at terminal phase (Vz/F) for E6742 in plasma
Time frame: Days 1 to 7
Cohorts 1, 2, 3, 5, and 6: Day 1 at predose and 0.5 (30 minutes), 1, 2, 3, 4, 6, 8, 10, and 12 hours postdose; Day 2 (24 and 36 hours postdose); Day 3 (48 hours postdose); Day 4 (72 hours postdose); Day 5 (96 hours postdose); Day 6 (120 hours postdose); Day 7 (144 hours postdose). Cohort 4: In both periods (Treatment Periods 1 [7 days] and 2 [6 days]), Day 1 at predose and 0.5 (30 minutes), 1, 2, 3, 4, 6, 8, 10, and 12 hours postdose; Day 2 (24 and 36 hours postdose); Day 3 (48 hours postdose); Day 4 (72 hours postdose); Day 5 (96 hours postdose); Day 6 (120 hours postdose); Day 7 (144 hours postdose).
AUC metabolite to E6742 ratio following molecular weight correction to E6742 equivalents in plasma
Time frame: Days 1 to 7
Cohorts 1, 2, 3, 5, and 6: Day 1 at predose and 0.5 (30 minutes), 1, 2, 3, 4, 6, 8, 10, and 12 hours postdose; Day 2 (24 and 36 hours postdose); Day 3 (48 hours postdose); Day 4 (72 hours postdose); Day 5 (96 hours postdose); Day 6 (120 hours postdose); Day 7 (144 hours postdose). Cohort 4: In both periods (Treatment Periods 1 [7 days] and 2 [6 days]), Day 1 at predose and 0.5 (30 minutes), 1, 2, 3, 4, 6, 8, 10, and 12 hours postdose; Day 2 (24 and 36 hours postdose); Day 3 (48 hours postdose); Day 4 (72 hours postdose); Day 5 (96 hours postdose); Day 6 (120 hours postdose); Day 7 (144 hours postdose).
Amount of unchanged drug excreted in urine (Ae) for E6742 and the metabolite ER-1132963
Time frame: Days 1 to 7
Cohorts 1, 2, 3, 5, and 6: Days 1 to 7: predose and 0 to 4, >4 to 8, >8 to 12, >12 to 24, >24 to 48, >48 to 72, >72 to 96, >96 to 120, and >120 to 144 hours postdose. Cohort 4: Days 1 to 7 (Treatment Period 1): predose and 0 to 4, >4 to 8, >8 to 12, >12 to 24, >24 to 48, >48 to 72, >72 to 96, >96 to 120, and >120 to 144 hours postdose.
Renal clearance (CLR)
Time frame: Days 1 to 7
Cohorts 1, 2, 3, 5, and 6: Days 1 to 7: predose and 0 to 4, >4 to 8, >8 to 12, >12 to 24, >24 to 48, >48 to 72, >72 to 96, >96 to 120, and >120 to 144 hours postdose. Cohort 4: Days 1 to 7 (Treatment Period 1): predose and 0 to 4, >4 to 8, >8 to 12, >12 to 24, >24 to 48, >48 to 72, >72 to 96, >96 to 120, and >120 to 144 hours postdose.
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 7 Sep 2018.
- Individual participant dataSharing planned: No
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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 E6742 in people with Healthy Participants, 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 2 inclusion and 19 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 7 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. Some participants in this study may receive a placebo. 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?
Number of participants with any serious adverse event and number of participants with any non-serious adverse event (time frame: from Screening up to Day 7). The study lists 13 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 7 Sep 2018.