Healthy VolunteersPhase 1NCT04223960
A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, Bioavailability, and Food-effects of EA1080 in Healthy Caucasian and Japanese Male Participants
A Phase 1 study testing EA1080 in people with Healthy Volunteers, run by EA Pharma Co., Ltd. at 1 site in United Kingdom.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- EA1080
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 184 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 9 Jan 2020to 6 Aug 2023
- 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
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Participants must meet all of the following criteria to be eligible for enrolment in this study:
- Participants in Caucasian cohorts must be healthy males, aged greater than or equal (>=) 18 to less than or equal to (<=) 45 years at the date of signing informed consent
- Participants in Japanese cohorts must be healthy males, aged >=20 to <=45 years at the date of signing informed consent
- Participants must have a body mass index (BMI) between 18.5-25.0 kilogram per square meter (kg/m^2) inclusive at screening, Day -3, Day -2 or Day -1.
Who cannot join
- Participants will be excluded from enrolment in this study if they meet any of the following criteria:
- Positive test for Hepatitis B surface antigen (HBsAg), Hepatitis C antibody (HCV Ab), or human immunodeficiency virus antibody (HIV Ab) at screening
- Consumption of herbal remedies or dietary supplements containing St. John's Wort 30 days before the first day of dosing
- Has donated or lost 400 milliliter (mL) blood or more within the last 16 weeks preceding the first day of dosing
- An inability to follow a standardised diet and meal schedule or inability to fast, as required during the study
- Prior screen failure (where the cause of the screen failure is not deemed to be temporary), randomisation, participation, or enrolment in this study. Participants who initially failed due to temporary non-medically significant issues are eligible for re-screening once the cause has resolved
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- Participants with veins on either arm that are unsuitable for intravenous puncture or cannulation (example, veins that are difficult to locate, or a tendency to rupture during puncture)
- Participants with any medical condition which may cause raised intracranial pressure, participants with new or changing headaches, and participants with history of head or spinal trauma
- An absolute lymphocyte count below 0.9*10^9 per liter (/L) at screening or on Day -1
- Participants in receipt of any vaccination for Corona virus disease (COVID-19) within 14 days prior to the first dose administration.
- History of COVID-19 polymerase chain reaction (PCR) positivity within 3 months of Day 1, suspected COVID-19 based on clinical presentation within 3 months of Day 1, or presence of clinically relevant long term sequelae of COVID-19.
- Unwillingness to receive COVID-19 testing per local or site COVID-19 guidance.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A First-in-human, Randomized, Double-blinded, Placebo-controlled, Single and Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, Bioavailability and Food-effects of EA1080 in Healthy Caucasian and Japanese Male Volunteers
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.
Read the detailed description
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:
- Single ascending dose (SAD)
- Food Effect (FE) and optional bioavailability
- Multiple ascending dose (MAD)
Part B: This part of study is comprised of four sub-parts to assess Formulation E and Formulation F as follows:
- SAD
- An additional FE period in SAD cohorts (SAD-FE)
- Food Effect and bioavailability (FE/BA)
- MAD
- Conditions
- Healthy Volunteers
- Being tested
- EA1080, EA1080-matching placebo
- Keywords
- EA1080, Pharmacokinetics, Food effect study, Pharmacodynamics
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EA1080Drug
EA1080 Formulation A.
EA1080Drug
EA1080 Formulation B.
EA1080Drug
EA1080 Formulation C.
EA1080Drug
EA1080 Formulation D.
EA1080-matching placeboDrug
EA1080-matching placebo.
EA1080Drug
EA1080 Formulation E.
EA1080Drug
EA1080 Formulation F.
| Study group | Role | What they receive |
|---|---|---|
| Part A: SAD, EA1080 Formulation A in Healthy Caucasian Participants | Experimental | 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). Receives: Drug: EA1080; Drug: EA1080-matching placebo |
| Part A: SAD, EA1080 Formulation B in Healthy Caucasian Participants | Experimental | 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). Receives: Drug: EA1080; Drug: EA1080-matching placebo |
| Part A: SAD, EA1080 Formulation C in Healthy Caucasian Participants | Experimental | 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). Receives: Drug: EA1080; Drug: EA1080-matching placebo |
| Part A: SAD, EA1080 Formulation D in Healthy Caucasian Participants | Experimental | 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). Receives: Drug: EA1080; Drug: EA1080-matching placebo |
| Part A: SAD, EA1080 in Healthy Japanese Participants (Optional) | Experimental | 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. Receives: Drug: EA1080; Drug: EA1080-matching placebo |
| Part A: FE and Optional BA in Healthy Caucasian Participants | Experimental | 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. Receives: Drug: EA1080 |
| Part A: FE and Optional BA, in Healthy Japanese Participants | Experimental | 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. Receives: Drug: EA1080 |
| Part A: MAD, EA1080 Formulation A in Healthy Caucasian Participants | Experimental | 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). Receives: Drug: EA1080; Drug: EA1080-matching placebo |
| Part A: MAD, EA1080 Formulation B in Healthy Caucasian Participants | Experimental | 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). Receives: Drug: EA1080; Drug: EA1080-matching placebo |
| Part A: MAD, EA1080 Formulation C in Healthy Caucasian Participants | Experimental | 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). Receives: Drug: EA1080; Drug: EA1080-matching placebo |
| Part A: MAD, EA1080 Formulation D in Healthy Caucasian Participants | Experimental | 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). Receives: Drug: EA1080; Drug: EA1080-matching placebo |
| Part A: MAD, EA1080 in Healthy Japanese Participants (Optional) | Experimental | 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. Receives: Drug: EA1080; Drug: EA1080-matching placebo |
| Part B: SAD, EA1080 Formulation E in Healthy Caucasian Participants | Experimental | 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). Receives: Drug: EA1080-matching placebo; Drug: EA1080 |
| Part B: SAD, EA1080 Formulation E in Healthy Japanese Participants | Experimental | 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). Receives: Drug: EA1080-matching placebo; Drug: EA1080 |
| Part B: SAD, EA1080 Formulation F in Healthy Caucasian Participants | Experimental | 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). Receives: Drug: EA1080-matching placebo; Drug: EA1080 |
| Part B: SAD, EA1080 Formulation F in Healthy Japanese Participants | Experimental | 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). Receives: Drug: EA1080-matching placebo; Drug: EA1080 |
| Part B: SAD-FE, EA1080 Formulation E in Healthy Caucasian Participants | Experimental | 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. Receives: Drug: EA1080-matching placebo; Drug: EA1080 |
| Part B: SAD-FE, EA1080 Formulation E in Healthy Japanese Participants | Experimental | 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. Receives: Drug: EA1080-matching placebo; Drug: EA1080 |
| Part B: SAD-FE, EA1080 Formulation F in Healthy Caucasian Participants | Experimental | 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. Receives: Drug: EA1080-matching placebo; Drug: EA1080 |
| Part B: SAD-FE, EA1080 Formulation F in Healthy Japanese Participants | Experimental | 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. Receives: Drug: EA1080-matching placebo; Drug: EA1080 |
| Part B: FE/BA, in Healthy Caucasian Participants | Experimental | 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. Receives: Drug: EA1080 |
| Part B: FE/BA, in Healthy Japanese Participants | Experimental | 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. Receives: Drug: EA1080 |
| Part B: MAD, EA1080 Formulation E in Healthy Caucasian Participants | Experimental | 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). Receives: Drug: EA1080-matching placebo; Drug: EA1080 |
| Part B: MAD, EA1080 Formulation E in Healthy Japanese Participants | Experimental | 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). Receives: Drug: EA1080-matching placebo; Drug: EA1080 |
| Part B: MAD, EA1080 Formulation F in Healthy Caucasian Participants | Experimental | 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). Receives: Drug: EA1080-matching placebo; Drug: EA1080 |
| Part B: MAD, EA1080 Formulation F in Healthy Japanese Participants | Experimental | 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). Receives: Drug: EA1080-matching placebo; Drug: EA1080 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Parts A and B: Number of Participants With Treatment-emergent Adverse Events (TEAEs)
Measured: Up to approximately 3 year 4 months
Parts A and B: Percentage of Participants With Clinically Significant Change From Baseline in Laboratory Parameter Values
Measured: 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
Measured: Up to approximately 3 year 4 months
Parts A and B: Percentage of Participants With Clinically Significant Change From Baseline in Vital Sign Values
Measured: Up to approximately 3 year 4 months
Secondary outcomes (20)
Parts A and B: Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) of EA1080 and its Metabolite
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2020
- Study start9 Jan 2020
- Primary completion6 Aug 2023
- Study completion6 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies of the same condition, open and under way.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 184 participants (actual)
Sponsor and investigators
- Lead sponsor
- EA Pharma Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04223960
- Sponsor's protocol ID
- EA1080-CP1
- Other IDs
- 2019-001886-34, 2019
- Status last verified
- Jul 2023
- First submitted
- 2 Jan 2020
- Last updated
- 26 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A First-in-human, Randomized, Double-blinded, Placebo-controlled, Single and Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, Bioavailability and Food-effects of EA1080 in Healthy Caucasian and Japanese Male Volunteers
- ClinicalTrials.gov ID
- NCT04223960
- Acronym / sponsor ID
- EA1080-CP1
- Conditions
- Healthy Volunteers
- Keywords
- EA1080, Pharmacokinetics, Food effect study, Pharmacodynamics
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 184 participants (actual)
- Lead sponsor
- EA Pharma Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 9 Jan 2020 (actual)
- Primary completion
- 6 Aug 2023 (actual)
- Study completion
- 6 Aug 2023 (actual)
- First posted
- 13 Jan 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The 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.
Detailed description
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:
- Single ascending dose (SAD)
- Food Effect (FE) and optional bioavailability
- Multiple ascending dose (MAD)
Part B: This part of study is comprised of four sub-parts to assess Formulation E and Formulation F as follows:
- SAD
- An additional FE period in SAD cohorts (SAD-FE)
- Food Effect and bioavailability (FE/BA)
- MAD
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 26
| Arm | Type | Receives |
|---|---|---|
| Part A: SAD, EA1080 Formulation A in Healthy Caucasian Participants | Experimental | Drug: EA1080, Drug: EA1080-matching placeboHealthy 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). |
| Part A: SAD, EA1080 Formulation B in Healthy Caucasian Participants | Experimental | Drug: EA1080, Drug: EA1080-matching placeboHealthy 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). |
| Part A: SAD, EA1080 Formulation C in Healthy Caucasian Participants | Experimental | Drug: EA1080, Drug: EA1080-matching placeboHealthy 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). |
| Part A: SAD, EA1080 Formulation D in Healthy Caucasian Participants | Experimental | Drug: EA1080, Drug: EA1080-matching placeboHealthy 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). |
| Part A: SAD, EA1080 in Healthy Japanese Participants (Optional) | Experimental | Drug: EA1080, Drug: EA1080-matching placeboHealthy 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. |
| Part A: FE and Optional BA in Healthy Caucasian Participants | Experimental | Drug: EA1080Healthy 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. |
| Part A: FE and Optional BA, in Healthy Japanese Participants | Experimental | Drug: EA1080Healthy 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. |
| Part A: MAD, EA1080 Formulation A in Healthy Caucasian Participants | Experimental | Drug: EA1080, Drug: EA1080-matching placeboHealthy 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). |
| Part A: MAD, EA1080 Formulation B in Healthy Caucasian Participants | Experimental | Drug: EA1080, Drug: EA1080-matching placeboHealthy 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). |
| Part A: MAD, EA1080 Formulation C in Healthy Caucasian Participants | Experimental | Drug: EA1080, Drug: EA1080-matching placeboHealthy 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). |
| Part A: MAD, EA1080 Formulation D in Healthy Caucasian Participants | Experimental | Drug: EA1080, Drug: EA1080-matching placeboHealthy 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). |
| Part A: MAD, EA1080 in Healthy Japanese Participants (Optional) | Experimental | Drug: EA1080, Drug: EA1080-matching placeboHealthy 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. |
| Part B: SAD, EA1080 Formulation E in Healthy Caucasian Participants | Experimental | Drug: EA1080-matching placebo, Drug: EA1080Healthy 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). |
| Part B: SAD, EA1080 Formulation E in Healthy Japanese Participants | Experimental | Drug: EA1080-matching placebo, Drug: EA1080Healthy 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). |
| Part B: SAD, EA1080 Formulation F in Healthy Caucasian Participants | Experimental | Drug: EA1080-matching placebo, Drug: EA1080Healthy 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). |
| Part B: SAD, EA1080 Formulation F in Healthy Japanese Participants | Experimental | Drug: EA1080-matching placebo, Drug: EA1080Healthy 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). |
| Part B: SAD-FE, EA1080 Formulation E in Healthy Caucasian Participants | Experimental | Drug: EA1080-matching placebo, Drug: EA1080Healthy 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. |
| Part B: SAD-FE, EA1080 Formulation E in Healthy Japanese Participants | Experimental | Drug: EA1080-matching placebo, Drug: EA1080Healthy 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. |
| Part B: SAD-FE, EA1080 Formulation F in Healthy Caucasian Participants | Experimental | Drug: EA1080-matching placebo, Drug: EA1080Healthy 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. |
| Part B: SAD-FE, EA1080 Formulation F in Healthy Japanese Participants | Experimental | Drug: EA1080-matching placebo, Drug: EA1080Healthy 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. |
| Part B: FE/BA, in Healthy Caucasian Participants | Experimental | Drug: EA1080Healthy 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. |
| Part B: FE/BA, in Healthy Japanese Participants | Experimental | Drug: EA1080Healthy 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. |
| Part B: MAD, EA1080 Formulation E in Healthy Caucasian Participants | Experimental | Drug: EA1080-matching placebo, Drug: EA1080Healthy 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). |
| Part B: MAD, EA1080 Formulation E in Healthy Japanese Participants | Experimental | Drug: EA1080-matching placebo, Drug: EA1080Healthy 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). |
| Part B: MAD, EA1080 Formulation F in Healthy Caucasian Participants | Experimental | Drug: EA1080-matching placebo, Drug: EA1080Healthy 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). |
| Part B: MAD, EA1080 Formulation F in Healthy Japanese Participants | Experimental | Drug: EA1080-matching placebo, Drug: EA1080Healthy 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). |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Participants must meet all of the following criteria to be eligible for enrolment in this study:
- Participants in Caucasian cohorts must be healthy males, aged greater than or equal (>=) 18 to less than or equal to (<=) 45 years at the date of signing informed consent
- Participants in Japanese cohorts must be healthy males, aged >=20 to <=45 years at the date of signing informed consent
- Participants must have a body mass index (BMI) between 18.5-25.0 kilogram per square meter (kg/m^2) inclusive at screening, Day -3, Day -2 or Day -1.
Key exclusion criteria (12 listed)
- Participants will be excluded from enrolment in this study if they meet any of the following criteria:
- Positive test for Hepatitis B surface antigen (HBsAg), Hepatitis C antibody (HCV Ab), or human immunodeficiency virus antibody (HIV Ab) at screening
- Consumption of herbal remedies or dietary supplements containing St. John's Wort 30 days before the first day of dosing
- Has donated or lost 400 milliliter (mL) blood or more within the last 16 weeks preceding the first day of dosing
- An inability to follow a standardised diet and meal schedule or inability to fast, as required during the study
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 |
|---|---|---|
| EA1080EA1080 Formulation A. | Drug | Part A: FE and Optional BA in Healthy Caucasian Participants, Part A: FE and Optional BA, in Healthy Japanese Participants, Part A: MAD, EA1080 Formulation A in Healthy Caucasian Participants, Part A: MAD, EA1080 in Healthy Japanese Participants (Optional), Part A: SAD, EA1080 Formulation A in Healthy Caucasian Participants, Part A: SAD, EA1080 in Healthy Japanese Participants (Optional) |
| EA1080EA1080 Formulation B. | Drug | Part A: FE and Optional BA in Healthy Caucasian Participants, Part A: FE and Optional BA, in Healthy Japanese Participants, Part A: MAD, EA1080 Formulation B in Healthy Caucasian Participants, Part A: MAD, EA1080 in Healthy Japanese Participants (Optional), Part A: SAD, EA1080 Formulation B in Healthy Caucasian Participants, Part A: SAD, EA1080 in Healthy Japanese Participants (Optional) |
| EA1080EA1080 Formulation C. | Drug | Part A: FE and Optional BA in Healthy Caucasian Participants, Part A: FE and Optional BA, in Healthy Japanese Participants, Part A: MAD, EA1080 Formulation C in Healthy Caucasian Participants, Part A: MAD, EA1080 in Healthy Japanese Participants (Optional), Part A: SAD, EA1080 Formulation C in Healthy Caucasian Participants, Part A: SAD, EA1080 in Healthy Japanese Participants (Optional) |
| EA1080EA1080 Formulation D. | Drug | Part A: FE and Optional BA in Healthy Caucasian Participants, Part A: FE and Optional BA, in Healthy Japanese Participants, Part A: MAD, EA1080 Formulation D in Healthy Caucasian Participants, Part A: MAD, EA1080 in Healthy Japanese Participants (Optional), Part A: SAD, EA1080 Formulation D in Healthy Caucasian Participants, Part A: SAD, EA1080 in Healthy Japanese Participants (Optional) |
| EA1080-matching placeboEA1080-matching placebo. | Drug | Part A: MAD, EA1080 Formulation A in Healthy Caucasian Participants, Part A: MAD, EA1080 Formulation B in Healthy Caucasian Participants, Part A: MAD, EA1080 Formulation C in Healthy Caucasian Participants, Part A: MAD, EA1080 Formulation D in Healthy Caucasian Participants, Part A: MAD, EA1080 in Healthy Japanese Participants (Optional), Part A: SAD, EA1080 Formulation A in Healthy Caucasian Participants, Part A: SAD, EA1080 Formulation B in Healthy Caucasian Participants, Part A: SAD, EA1080 Formulation C in Healthy Caucasian Participants, Part A: SAD, EA1080 Formulation D in Healthy Caucasian Participants, Part A: SAD, EA1080 in Healthy Japanese Participants (Optional), Part B: MAD, EA1080 Formulation E in Healthy Caucasian Participants, Part B: MAD, EA1080 Formulation E in Healthy Japanese Participants, Part B: MAD, EA1080 Formulation F in Healthy Caucasian Participants, Part B: MAD, EA1080 Formulation F in Healthy Japanese Participants, Part B: SAD, EA1080 Formulation E in Healthy Caucasian Participants, Part B: SAD, EA1080 Formulation E in Healthy Japanese Participants, Part B: SAD, EA1080 Formulation F in Healthy Caucasian Participants, Part B: SAD, EA1080 Formulation F in Healthy Japanese Participants, Part B: SAD-FE, EA1080 Formulation E in Healthy Caucasian Participants, Part B: SAD-FE, EA1080 Formulation E in Healthy Japanese Participants, Part B: SAD-FE, EA1080 Formulation F in Healthy Caucasian Participants, Part B: SAD-FE, EA1080 Formulation F in Healthy Japanese Participants |
| EA1080EA1080 Formulation E. | Drug | Part B: FE/BA, in Healthy Caucasian Participants, Part B: FE/BA, in Healthy Japanese Participants, Part B: MAD, EA1080 Formulation E in Healthy Caucasian Participants, Part B: MAD, EA1080 Formulation E in Healthy Japanese Participants, Part B: SAD, EA1080 Formulation E in Healthy Caucasian Participants, Part B: SAD, EA1080 Formulation E in Healthy Japanese Participants, Part B: SAD-FE, EA1080 Formulation E in Healthy Caucasian Participants, Part B: SAD-FE, EA1080 Formulation E in Healthy Japanese Participants |
| EA1080EA1080 Formulation F. | Drug | Part B: FE/BA, in Healthy Caucasian Participants, Part B: FE/BA, in Healthy Japanese Participants, Part B: MAD, EA1080 Formulation F in Healthy Caucasian Participants, Part B: MAD, EA1080 Formulation F in Healthy Japanese Participants, Part B: SAD, EA1080 Formulation F in Healthy Caucasian Participants, Part B: SAD, EA1080 Formulation F in Healthy Japanese Participants, Part B: SAD-FE, EA1080 Formulation F in Healthy Caucasian Participants, Part B: SAD-FE, EA1080 Formulation F in Healthy Japanese Participants |
Primary outcome
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
20 secondary outcomes
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
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 26 Dec 2023.
- 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 EA1080 in people with Healthy Volunteers, run by EA Pharma Co., Ltd. at 1 site in United Kingdom.
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 4 inclusion and 12 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 26 Dec 2023. 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 Kingdom. 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?
Parts A and B: Number of Participants With Treatment-emergent Adverse Events (TEAEs) (time frame: Up to approximately 3 year 4 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Dec 2023.