Healthy ParticipantsPhase 1NCT03133468
Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of AJM347 in Healthy Male Caucasian and Japanese Subjects in the Fasted and Fed State
A Phase 1 study testing AJM347 in people with Healthy Participants, run by EA Pharma Co., Ltd. at 1 site in United Kingdom.
Trial summary
This study will be conducted to determine the safety and tolerability of single and multiple oral ascending doses of AJM347 in healthy male participants, and to assess the pharmacodynamic response following single and multiple oral ascending doses of AJM347 in the same population. 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 Participants
- What is being tested?
- AJM347
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 200 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 25 Jul 2017to 6 Jul 2018
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Main Inclusion Criteria for all participants:
- Participants will be male
- Participants will be in good health
- Main Inclusion Criteria for Japanese participants:
- Be ≥20 to ≤45 years of age
- Have body mass index (BMI) ≥18.5 to ≤25.0 kilograms per meters squared (kg/m^2)
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- Be Japanese
- Main Inclusion Criteria for Caucasian participants:
- Be ≥18 to ≤45 years of age
- Have a BMI ≥18.5 to ≤30.0 kg/m^2
- Be Caucasian
Who cannot join
- Main Exclusion Criteria for all participants:
- Participants will be excluded from the study if they satisfy any of the following criteria at the Screening visit, unless otherwise stated.
- Participants who have donated or lost ≥200 milliliters (mL) blood within 1 month or ≥400 mL within 3 months prior to Check-in
- Participants who have an abnormality in heart rate, blood pressure, temperature, or respiration rate at Screening
- Participants who have:
- a positive urine drugs of abuse screen;
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- a positive alcohol breath test
- Participants who have an abnormality in the 12-lead electrocardiogram (ECG) at Screening
- Participants who are still participating in another clinical study (eg, attending follow-up visits) or who have participated in a clinical study involving administration of an investigational drug (new chemical entity) in the past 3 months prior to first dose administration
- Participants who have a significant history of drug allergy, as determined by the Investigator
- Participants who have any clinically significant abnormal physical examination finding
- Participants who:
- are carriers of the hepatitis B surface antigen (HBsAg);
- are carriers of the hepatitis C antibody;
- have a positive result for the test for human immunodeficiency virus (HIV) antibodies
- Participants who, in the opinion of the Investigator, should not participate in this study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A First-in-Human, Randomised, Double Blind, Placebo Controlled, Single and Multiple Ascending Oral Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of AJM347 in Healthy Male Caucasian and Japanese Subjects in the Fasted and Fed State
This study will be conducted to determine the safety and tolerability of single and multiple oral ascending doses of AJM347 in healthy male participants, and to assess the pharmacodynamic response following single and multiple oral ascending doses of AJM347 in the same population. This study will also aim to determine the single and multiple oral ascending dose pharmacokinetics of AJM347 and its metabolite in healthy male participants, and to determine the effect of food on the single and multiple oral dose pharmacokinetics of AJM347 and its metabolite in the same population.
- Conditions
- Healthy Participants
- Being tested
- AJM347, Placebo
- Keywords
- AJM347, pharmacokinetics, food effect study, pharmacodynamics
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AJM347Drug
Oral administration
PlaceboDrug
Oral administration
| Study group | Role | What they receive |
|---|---|---|
| Part 1: AJM347 | Experimental | Caucasian and Japanese participants will be randomized to receive one of eight and four single oral doses of AJM347, respectively, administered in the fasted state on Day 1. Receives: Drug: AJM347 |
| Part 1: Placebo | Placebo comparator | Caucasian and Japanese participants will be randomized to receive one of eight and four single oral doses of matching placebo, respectively, administered in the fasted state on Day 1. Receives: Drug: Placebo |
| Part 2: Low-dose AJM347 | Experimental | Caucasian and Japanese participants will receive a "low" dose of AJM347 (at different frequencies and in either a fed or fasted state) on Day 1 of each of 6 sequential treatment periods. Receives: Drug: AJM347 |
| Part 2: High-dose AJM347 | Experimental | Caucasian and Japanese participants will receive a "high" dose of AJM347 (at different frequencies and in either a fed or fasted state) on Day 1 of each of 2 sequential treatment periods (the frequency and timing with respect to meals will be determined after review of the data from the low-dose AJM347 groups). Receives: Drug: AJM347 |
| Part 3: AJM347 | Experimental | Caucasian and Japanese participants will be randomized to receive one of three single doses of AJM347 on the morning of Day 1 and multiple daily doses beginning on the morning of Day 3, with the last dose received on the evening of Day 9. The actual doses, dosing frequencies, and timings with respect to meals to be employed in Part 3 of the study will be determined after review of the data from dose groups in Parts 1 and 2 of the study. Receives: Drug: AJM347 |
| Part 3: Placebo | Placebo comparator | Caucasian and Japanese participants will be randomized to receive one of three single doses of matching placebo on the morning of Day 1 and multiple daily doses beginning on the morning of Day 3, with the last dose received on the evening of Day 9. The actual doses, dosing frequencies, and timings with respect to meals to be employed in Part 3 of the study will be determined after review of the data from dose groups in Parts 1 and 2 of the study. 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 adverse event (AE)
An AE is any untoward medical occurrence in a patient or clinical investigation participant administered an investigational product. An AE does not necessarily have a causal relationship with the medicinal product.
Measured: Part 1, up to Days 7 to 9; Part 2, up to Days 7 to 9; Part 3, up to Day 15 (Parts 1, 2, and 3 are not continuous)
Secondary outcomes (7)
Number of participants with abnormal, clinically significant physical examination findings
Clinical significance will be determined by the investigator.
Measured: Part 1, up to Days 7 to 9; Part 2, up to Days 7 to 9; Part 3, up to Day 15 (Parts 1, 2, and 3 are not continuous)
Number of participants with abnormal, clinically significant vital sign values
Clinical significance will be determined by the investigator.
Measured: Part 1, up to Days 7 to 9; Part 2, up to Days 7 to 9; Part 3, up to Day 15 (Parts 1, 2, and 3 are not continuous)
Number of participants with abnormal, clinically significant 12-lead electrocardiogram (ECG) values
Clinical significance will be determined by the investigator.
Measured: Part 1, up to Days 7 to 9; Part 2, up to Days 7 to 9; Part 3, up to Day 15 (Parts 1, 2, and 3 are not continuous)
Number of participants with abnormal, clinically significant clinical laboratory values
Clinical significance will be determined by the investigator.
Measured: Part 1, up to Days 7 to 9; Part 2, up to Days 7 to 9; Part 3, up to Day 15 (Parts 1, 2, and 3 are not continuous)
Mean plasma concentrations of AJM347 and its metabolite
Blood samples will be collected at the specified time points for the determination of plasma concentrations of AJM347 and its metabolite.
Measured: Part 1, Days 1 to 3; Part 2, Days 1 to 3; Part 3, Days 1 to 3, Day 7, Days 9 to 11 (Parts 1, 2, and 3 are not continuous)
Mean urinary concentrations of AJM347 and its metabolite
Urine samples will be collected at the specified time points for the determination of urine concentrations of AJM347 and its metabolite.
Measured: Part 1, Days 1 to 3; Part 3, Days 1 to 10
Inhibition rate of ligand-binding activity
The rate of inhibition of ligand-protein binding will be measured.
Measured: Part 1, Days 1 and 2; Part 3, Days 1 and 2, Days 7, 9, and 10
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2017
- Study start25 Jul 2017
- Primary completion6 Jul 2018
- Study completion6 Jul 2018
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.
- 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
- 200 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
- NCT03133468
- Sponsor's protocol ID
- AJM347/CP1
- Other IDs
- 2017-000259-17, 1009306/8349634, 2017
- Status last verified
- Jul 2018
- First submitted
- 25 Apr 2017
- Last updated
- 29 Aug 2018
- 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 29 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A First-in-Human, Randomised, Double Blind, Placebo Controlled, Single and Multiple Ascending Oral Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of AJM347 in Healthy Male Caucasian and Japanese Subjects in the Fasted and Fed State
- ClinicalTrials.gov ID
- NCT03133468
- Acronym / sponsor ID
- AJM347/CP1
- Conditions
- Healthy Participants
- Keywords
- AJM347, pharmacokinetics, food effect study, pharmacodynamics
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- EA Pharma Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 25 Jul 2017 (actual)
- Primary completion
- 6 Jul 2018 (actual)
- Study completion
- 6 Jul 2018 (actual)
- First posted
- 28 Apr 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.
This study will be conducted to determine the safety and tolerability of single and multiple oral ascending doses of AJM347 in healthy male participants, and to assess the pharmacodynamic response following single and multiple oral ascending doses of AJM347 in the same population. This study will also aim to determine the single and multiple oral ascending dose pharmacokinetics of AJM347 and its metabolite in healthy male participants, and to determine the effect of food on the single and multiple oral dose pharmacokinetics of AJM347 and its metabolite in the same population.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Part 1: AJM347 | Experimental | Drug: AJM347Caucasian and Japanese participants will be randomized to receive one of eight and four single oral doses of AJM347, respectively, administered in the fasted state on Day 1. |
| Part 1: Placebo | Placebo comparator | Drug: PlaceboCaucasian and Japanese participants will be randomized to receive one of eight and four single oral doses of matching placebo, respectively, administered in the fasted state on Day 1. |
| Part 2: Low-dose AJM347 | Experimental | Drug: AJM347Caucasian and Japanese participants will receive a "low" dose of AJM347 (at different frequencies and in either a fed or fasted state) on Day 1 of each of 6 sequential treatment periods. |
| Part 2: High-dose AJM347 | Experimental | Drug: AJM347Caucasian and Japanese participants will receive a "high" dose of AJM347 (at different frequencies and in either a fed or fasted state) on Day 1 of each of 2 sequential treatment periods (the frequency and timing with respect to meals will be determined after review of the data from the low-dose AJM347 groups). |
| Part 3: AJM347 | Experimental | Drug: AJM347Caucasian and Japanese participants will be randomized to receive one of three single doses of AJM347 on the morning of Day 1 and multiple daily doses beginning on the morning of Day 3, with the last dose received on the evening of Day 9. The actual doses, dosing frequencies, and timings with respect to meals to be employed in Part 3 of the study will be determined after review of the data from dose groups in Parts 1 and 2 of the study. |
| Part 3: Placebo | Placebo comparator | Drug: PlaceboCaucasian and Japanese participants will be randomized to receive one of three single doses of matching placebo on the morning of Day 1 and multiple daily doses beginning on the morning of Day 3, with the last dose received on the evening of Day 9. The actual doses, dosing frequencies, and timings with respect to meals to be employed in Part 3 of the study will be determined after review of the data from dose groups in Parts 1 and 2 of the study. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (11 listed)
- Participants will be male
- Participants will be in good health
- Be ≥20 to ≤45 years of age
- Have body mass index (BMI) ≥18.5 to ≤25.0 kilograms per meters squared (kg/m^2)
- Be Japanese
Key exclusion criteria (16 listed)
- Participants will be excluded from the study if they satisfy any of the following criteria at the Screening visit, unless otherwise stated.
- Participants who have donated or lost ≥200 milliliters (mL) blood within 1 month or ≥400 mL within 3 months prior to Check-in
- Participants who have an abnormality in heart rate, blood pressure, temperature, or respiration rate at Screening
- Participants who have:
- Participants who have an abnormality in the 12-lead electrocardiogram (ECG) at Screening
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 |
|---|---|---|
| AJM347Oral administration | Drug | Part 1: AJM347, Part 2: High-dose AJM347, Part 2: Low-dose AJM347, Part 3: AJM347 |
| PlaceboOral administration | Drug | Part 1: Placebo, Part 3: Placebo |
Primary outcome
Number of participants with any adverse event (AE)
Time frame: Part 1, up to Days 7 to 9; Part 2, up to Days 7 to 9; Part 3, up to Day 15 (Parts 1, 2, and 3 are not continuous)
An AE is any untoward medical occurrence in a patient or clinical investigation participant administered an investigational product. An AE does not necessarily have a causal relationship with the medicinal product.
7 secondary outcomes
Number of participants with abnormal, clinically significant physical examination findings
Time frame: Part 1, up to Days 7 to 9; Part 2, up to Days 7 to 9; Part 3, up to Day 15 (Parts 1, 2, and 3 are not continuous)
Number of participants with abnormal, clinically significant vital sign values
Time frame: Part 1, up to Days 7 to 9; Part 2, up to Days 7 to 9; Part 3, up to Day 15 (Parts 1, 2, and 3 are not continuous)
Number of participants with abnormal, clinically significant 12-lead electrocardiogram (ECG) values
Time frame: Part 1, up to Days 7 to 9; Part 2, up to Days 7 to 9; Part 3, up to Day 15 (Parts 1, 2, and 3 are not continuous)
Number of participants with abnormal, clinically significant clinical laboratory values
Time frame: Part 1, up to Days 7 to 9; Part 2, up to Days 7 to 9; Part 3, up to Day 15 (Parts 1, 2, and 3 are not continuous)
Mean plasma concentrations of AJM347 and its metabolite
Time frame: Part 1, Days 1 to 3; Part 2, Days 1 to 3; Part 3, Days 1 to 3, Day 7, Days 9 to 11 (Parts 1, 2, and 3 are not continuous)
Mean urinary concentrations of AJM347 and its metabolite
Time frame: Part 1, Days 1 to 3; Part 3, Days 1 to 10
Inhibition rate of ligand-binding activity
Time frame: Part 1, Days 1 and 2; Part 3, Days 1 and 2, Days 7, 9, and 10
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 29 Aug 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 AJM347 in people with Healthy Participants, 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 11 inclusion and 16 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 29 Aug 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 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. 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 adverse event (AE) (time frame: Part 1, up to Days 7 to 9; Part 2, up to Days 7 to 9; Part 3, up to Day 15 (Parts 1, 2, and 3 are not continuous)). 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 29 Aug 2018.