A Phase 1 interventional study of EA1080 and EA1080 in Healthy Volunteers, sponsored by EA Pharma Co., Ltd.. Completed at 1 site in United Kingdom. Open to male participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-12-26.
Sponsored by EA Pharma Co., Ltd. (part of Eisai Co., Ltd.) · Phase 1, Interventional, and Other
The primary purpose of the study is to evaluate the safety and tolerability of EA1080 following single and multiple ascending oral doses in healthy Caucasian and Japanese male participants.
The drug being tested in this study is called EA1080. EA1080 is being tested to find a safe and well-tolerated dose in healthy Caucasian and Japanese male participants. The study consists of 2 parts as mentioned below:
Part A: This part of the study is fully adaptive and will be performed in three sub-parts as follows:
Part B: This part of study is comprised of four sub-parts to assess Formulation E and Formulation F as follows:
EA Pharma Co., Ltd. is the lead sponsor of 13 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Participants must meet all of the following criteria to be eligible for enrolment in this study:
Exclusion Criteria:
Participants will be excluded from enrolment in this study if they meet any of the following criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis C tests
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Healthy Caucasian participants will receive EA1080 Formulation A or matching placebo orally, once on Day 1 of SAD part of the study. In SAD, there will be a maximum of 7 dose levels (three-four planned cohorts and three optional cohorts).
Drug: EA1080 · Drug: EA1080-matching placebo
Healthy Caucasian participants will receive EA1080 Formulation B or matching placebo orally, once on Day 1 of SAD part of the study. In SAD, there will be a maximum of 7 dose levels (three-four planned cohorts and three optional cohorts).
Drug: EA1080 · Drug: EA1080-matching placebo
Healthy Caucasian participants will receive EA1080 Formulation C or matching placebo orally, once on Day 1 of SAD part of the study. In SAD, there will be a maximum of 7 dose levels (three-four planned cohorts and three optional cohorts).
Drug: EA1080 · Drug: EA1080-matching placebo
Healthy Caucasian participants will receive EA1080 Formulation D or matching placebo orally, once on Day 1 of SAD part of the study. In SAD, there will be a maximum of 7 dose levels (three-four planned cohorts and three optional cohorts).
Drug: EA1080 · Drug: EA1080-matching placebo
Healthy Japanese participants will receive any EA1080 formulation (Formulation A, Formulation B, Formulation C, and Formulation D) or matching placebo orally, once on Day 1 of SAD part of the study. There will be a maximum of six dose levels (three planned and three optional cohorts) per formulation.
Drug: EA1080 · Drug: EA1080-matching placebo
Healthy Caucasian participants will receive EA1080 on Day 1 and Day 8 in selected formulations (Formulation A, Formulation B, Formulation C, and Formulation D) in fed and fasted states. These formulations may be tested in any order or combination up to eight- way crossover design. The order will be dependent on the treatment sequence in which participants will be allocated to treatment. A washout period of 7 days will be maintained between the dosing days of each treatment periods.
Drug: EA1080
Healthy Japanese participants will receive EA1080 on Day 1 and Day 8 in selected formulations (Formulation A, Formulation B, Formulation C, and Formulation D) in fed and fasted states. These formulations may be tested in any order or combination up to four-way crossover design. The order will be dependent on the treatment sequence in which participants will be allocated to treatment. A washout period of 7 days will be maintained between the dosing days of each treatment periods.
Drug: EA1080
Healthy Caucasian participants will receive EA1080 Formulation A or matching placebo orally, once on Day 1 then multiple daily doses beginning on Day 8 up to Day 21 in MAD part of the study. In MAD, there will be a maximum of 6 dose levels (three planned cohorts and three optional cohorts).
Drug: EA1080 · Drug: EA1080-matching placebo
Healthy Caucasian participants will receive EA1080 Formulation B or matching placebo orally, once on Day 1 then multiple daily doses beginning on Day 8 up to Day 21 in MAD part of the study. In MAD, there will be a maximum of 6 dose levels (three planned cohorts and three optional cohorts).
Drug: EA1080 · Drug: EA1080-matching placebo
Healthy Caucasian participants will receive EA1080 Formulation C or matching placebo orally, once on Day 1 then multiple daily doses beginning on Day 8 up to Day 21 in MAD part of the study. In MAD, there will be a maximum of 6 dose levels (three planned cohorts and three optional cohorts).
Drug: EA1080 · Drug: EA1080-matching placebo
Healthy Caucasian participants will receive EA1080 Formulation D or matching placebo orally, once on Day 1 then multiple daily doses beginning on Day 8 up to Day 21 in MAD part of the study. In MAD, there will be a maximum of 6 dose levels (three planned dose level and three optional).
Drug: EA1080 · Drug: EA1080-matching placebo
Healthy Japanese participants will receive any EA1080 formulation (Formulation A, Formulation B, Formulation C, and Formulation D) or matching placebo orally, once on Day 1 then multiple daily doses beginning on Day 8 up to Day 21 in MAD part of the study. In MAD, there will be a maximum of 6 dose levels (three planned dose level and three optional) per formulation.
Drug: EA1080 · Drug: EA1080-matching placebo
Healthy Caucasian participants will receive EA1080 Formulation E or matching placebo orally, once on Day 1 of SAD part of the study (three planned cohorts and six optional cohorts).
Drug: EA1080-matching placebo · Drug: EA1080
Healthy Japanese participants will receive EA1080 Formulation E or matching placebo orally, once on Day 1 of SAD part of the study (three planned cohorts and six optional cohorts).
Drug: EA1080-matching placebo · Drug: EA1080
Healthy Caucasian participants will receive EA1080 Formulation F or matching placebo orally, once on Day 1 of SAD part of the study (three planned cohorts and six optional cohorts).
Drug: EA1080-matching placebo · Drug: EA1080
Healthy Japanese participants will receive EA1080 Formulation E or matching placebo orally, once on Day 1 of SAD part of the study (three planned cohorts and six optional cohorts).
Drug: EA1080-matching placebo · Drug: EA1080
Healthy Caucasian participants will receive EA1080 Formulation E or matching placebo on Day 1 in fasted state followed by EA1080 Formulation E on Day 8 in fed states. A washout period of 6 days will be maintained between the dosing days.
Drug: EA1080-matching placebo · Drug: EA1080
Healthy Japanese participants will receive EA1080 Formulation E or matching placebo on Day 1 in fasted state followed by EA1080 Formulation E on Day 8 in fed states. A washout period of 6 days will be maintained between the dosing days.
Drug: EA1080-matching placebo · Drug: EA1080
Healthy Caucasian participants will receive EA1080 Formulation F or matching placebo on Day 1 in fasted state followed by EA1080 Formulation F on Day 8 in fed states. A washout period of 6 days will be maintained between the dosing days.
Drug: EA1080-matching placebo · Drug: EA1080
Healthy Japanese participants will receive EA1080 Formulation F or matching placebo on Day 1 in fasted state followed by EA1080 Formulation F on Day 8 in fed states. A washout period of 6 days will be maintained between the dosing days.
Drug: EA1080-matching placebo · Drug: EA1080
Healthy Caucasian participants will receive EA1080 on Days 1 8 and 15 in selected formulations (Formulation E in fasted state, Formulation F in fasted state, Formulation F in fed state). These formulations will be tested in a crossover design. The order will be dependent on the treatment sequence in which participants will be allocated to treatment. A washout period of 6 days will be maintained between the dosing days of each treatment periods.
Drug: EA1080
Healthy Japanese participants will receive EA1080 on Days 1 8 and 15 in selected formulations (Formulation E in fasted state, Formulation F in fasted state, Formulation F in fed state). These formulations will be tested in a crossover design. The order will be dependent on the treatment sequence in which participants will be allocated to treatment. A washout period of 6 days will be maintained between the dosing days of each treatment periods.
Drug: EA1080
Healthy Caucasian participants will receive EA1080 Formulation E or matching placebo orally, once on Day 1 then multiple daily doses beginning on Day 8 up to Day 17 in Part B, MAD of the study. In Part B, MAD, there will be a maximum of 6 dose levels (one-three planned dose level and six optional).
Drug: EA1080-matching placebo · Drug: EA1080
Healthy Japanese participants will receive EA1080 Formulation E or matching placebo orally, once on Day 1 then multiple daily doses beginning on Day 8 up to Day 17 in Part B, MAD of the study. In Part B, MAD, there will be a maximum of 6 dose levels (one-three planned dose level and six optional).
Drug: EA1080-matching placebo · Drug: EA1080
Healthy Caucasian participants will receive EA1080 Formulation F or matching placebo orally, once on Day 1 then multiple daily doses beginning on Day 8 up to Day 17 in Part B, MAD of the study. In Part B, MAD, there will be a maximum of 6 dose levels (one-three planned dose level and six optional).
Drug: EA1080-matching placebo · Drug: EA1080
Healthy Japanese participants will receive EA1080 Formulation F or matching placebo orally, once on Day 1 then multiple daily doses beginning on Day 8 up to Day 17 in Part B, MAD of the study. In Part B, MAD, there will be a maximum of 6 dose levels (one-three planned dose level and six optional).
Drug: EA1080-matching placebo · Drug: EA1080
EA1080 Formulation A.
EA1080 Formulation B.
EA1080 Formulation C.
EA1080 Formulation D.
EA1080-matching placebo.
EA1080 Formulation E.
EA1080 Formulation F.
Parts A and B: Number of Participants With Treatment-emergent Adverse Events (TEAEs)
Time frame: Up to approximately 3 year 4 months
Parts A and B: Percentage of Participants With Clinically Significant Change From Baseline in Laboratory Parameter Values
Time frame: Up to approximately 3 year 4 months
Parts A and B: Percentage of Participants With Abnormal, Clinically Significant Change From Baseline in 12-lead Electrocardiogram (ECG) Findings
Time frame: Up to approximately 3 year 4 months
Parts A and B: Percentage of Participants With Clinically Significant Change From Baseline in Vital Sign Values
Time frame: Up to approximately 3 year 4 months
Parts A and B: Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) of EA1080 and its Metabolite
Time frame: Part A and B, SAD: Pre-dose (Day 1) and up to Day 8; Part A, FE and Part B, SAD and additional FE: Pre-dose (Day 1) and up to Day 15; Part B, FE/BA: Pre-dose (Day 1) and up to Day 22; MAD: Pre-dose (Day 1) and up to Day 28 Part A and up to Day 24 Part B
Parts A and B: T1/2: Terminal Half-life of EA1080 and its Metabolite
Time frame: Part A and B, SAD: Pre-dose (Day 1) and up to Day 8; Part A, FE and Part B, SAD and additional FE: Pre-dose (Day 1) and up to Day 15; Part B, FE/BA: Pre-dose (Day 1) and up to Day 22; MAD: Pre-dose (Day 1) and up to Day 28 Part A and up to Day 24 Part B
Parts A and B: Cmax: Maximum Observed Plasma Concentration of EA1080 and its Metabolite
Time frame: Part A and B, SAD: Pre-dose (Day 1) and up to Day 8; Part A, FE and Part B, SAD and additional FE: Pre-dose (Day 1) and up to Day 15; Part B, FE/BA: Pre-dose (Day 1) and up to Day 22; MAD: Pre-dose (Day 1) and up to Day 28 Part A and up to Day 24 Part B
Parts A and B: AUC (0-t): Area Under the Concentration-time Curve From Time Zero to Time of Last Quantifiable Concentration of EA1080 and its Metabolite
Time frame: Part A and B, SAD: Pre-dose (Day 1) and up to Day 8; Part A, FE and Part B, SAD and additional FE: Pre-dose (Day 1) and up to Day 15; Part B, FE/BA: Pre-dose (Day 1) and up to Day 22; MAD: Pre-dose (Day 1) and up to Day 28 Part A and up to Day 24 Part B
Parts A and B: AUC (0-inf): Area Under the Concentration-time Curve From Time Zero Extrapolated to Infinite Time of EA1080 and its Metabolite
Time frame: Part A and B, SAD: Pre-dose (Day 1) and up to Day 8; Part A, FE and Part B, SAD and additional FE: Pre-dose (Day 1) and up to Day 15; Part B, FE/BA: Pre-dose (Day 1) and up to Day 22; MAD: Pre-dose (Day 1) and up to Day 28 Part A and up to Day 24 Part B
Parts A and B: %AUCextrap: Percentage of AUC (0-inf) That is due to Extrapolation From tlast to Infinity of EA1080 and its Metabolite
Time frame: SAD: Pre-dose (Day 1) and up to Day 8; FE and optional BA: Pre-dose (Day 1) and up to Day 15; MAD: Pre-dose (Day 1) and up to Day 28 Part A and up to Day 24 Part B
Parts A and B: CL/F: Apparent Total Body Clearance of EA1080 and its Metabolite
Time frame: Part A and B, SAD: Pre-dose (Day 1) and up to Day 8; Part A, FE and Part B, SAD and additional FE: Pre-dose (Day 1) and up to Day 15; Part B, FE/BA: Pre-dose (Day 1) and up to Day 22; MAD: Pre-dose (Day 1) and up to Day 28 Part A and up to Day 24 Part B
Parts A and B: Vz/F: Apparent Volume of Distribution During the Terminal Phase of EA1080 and its Metabolite
Time frame: Part A and B, SAD: Pre-dose (Day 1) and up to Day 8; Part A, FE and Part B, SAD and additional FE: Pre-dose (Day 1) and up to Day 15; Part B, FE/BA: Pre-dose (Day 1) and up to Day 22; MAD: Pre-dose (Day 1) and up to Day 28 Part A and up to Day 24 Part B
Parts A and B: Ae: Amount of Drug EA1080 Excreted in Urine
Time frame: Part A and B, SAD: Pre-dose (Day 1) and up to Day 5; Part B, SAD and additional FE: Pre-dose (Day 1) and up to Day 5; Part A and B, MAD: Pre-dose (Day 1) and up to Day 25 Part A and Day 21 for Part B
Parts A and B: fe: Percentage of EA1080 and its Metabolite Dose Excreted in Urine
Time frame: Part A and B, SAD: Pre-dose (Day 1) and up to Day 5; Part B, SAD and additional FE: Pre-dose (Day 1) and up to Day 5; MAD: Pre-dose (Day 1) and up to Day 25 Part A and Day 21 for Part B
Parts A and B: CLR: Renal Clearance of EA1080 and its Metabolite
Time frame: Part A and B, SAD: Pre-dose (Day 1) and up to Day 5; Part B, SAD and additional FE: Pre-dose (Day 1) and up to Day 5; MAD: Pre-dose (Day 1) and up to Day 25 Part A and Day 21 for Part B
Parts A and B: AUC (0-τ): Area Under the Plasma Concentration-time Curve From Time Zero to the Final Dosing Interval (τ) of EA1080 and its Metabolite
Time frame: MAD: Pre-dose (Day 1) and up to Day 28 Part A and up to Day 24 Part B
Parts A and Part B: Ctrough: Measured Plasma Concentration at the end of Each Dosing Interval of EA1080 and its Metabolite
Time frame: MAD: Pre-dose (Day 1) and up to Day 28 Part A and up to Day 24 Part B
Parts A and Part B: Cmax: Maximum Plasma Concentration Over the Dosing Period of EA1080 and its Metabolite
Time frame: MAD: Pre-dose (Day 1) and up to Day 28 Part A and up to Day 24 Part B
Parts A and Part B: AR(AUC): Accumulation Ratio For AUC0-τ of EA1080 and its Metabolite
Time frame: MAD: Pre-dose (Day 1) and up to Day 28 Part A and up to Day 24 Part B
Parts A and Part B: AR(Cmax): Accumulation Ratio For Cmax of EA1080 and its Metabolite
Time frame: MAD: Pre-dose (Day 1) and up to Day 28 Part A and up to Day 24 Part B
Parts A and Part B: AUC of EA1080 in Each Formulation
Time frame: Part A and B, SAD: Pre-dose (Day 1) and up to Day 8; Part A, FE and Part B, SAD and additional FE: Pre-dose (Day 1) and up to Day 15; Part B, FE/BA: Pre-dose (Day 1) and up to Day 22; MAD: Pre-dose (Day 1) and up to Day 28 Part A and up to Day 24 Part B
Parts A and Part B: Cmax of EA1080 in Each Formulation
Time frame: Part A and B, SAD: Pre-dose (Day 1) and up to Day 8; Part A, FE and Part B, SAD and additional FE: Pre-dose (Day 1) and up to Day 15; Part B, FE/BA: Pre-dose (Day 1) and up to Day 22; MAD: Pre-dose (Day 1) and up to Day 28 Part A and up to Day 24 Part B
Parts A and Part B: AUC of EA1080 in Fed and Fasted State
Time frame: Part A, FE: Pre-dose (Day 1) and up to Day 15; Part B SAD and additional FE: Pre-dose (Day 1) and up to Day 15; Part B, FE/BA: Pre-dose (Day 1) and up to Day 22
Parts A and Part B: Cmax of EA1080 in Fed and Fasted State
Time frame: Part A, FE: Pre-dose (Day 1) and up to Day 15; Part B SAD and additional FE: Pre-dose (Day 1) and up to Day 15; Part B, FE/BA: Pre-dose (Day 1) and up to Day 22
Plan to share: No
No publications or documents are linked to this record.
Ran from Jan 2020 to primary completion in Aug 2023, 42 months.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jul 2023. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.