HealthyPhase 1NCT03618316
Effect of Cimetidine on the PK of Imeglimin
A Phase 1 study testing Imeglimin and Cimetidine in people with Healthy, run by Poxel SA at 1 site in United Kingdom.
Trial summary
The trial is an open-label assessment of the interaction of imeglimin with cimetidine. Up to 16 healthy men and women will receive a single oral dose of 1,500 mg imeglimin alone followed by a second dose of imeglimin during repeated doses of 400 mg cimetidine taken twice daily for 6 days. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Imeglimin and Cimetidine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 19 Jun 2018to 27 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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- BMI : 18.5-29.9
- Body weight ≥ 60 kg
- willing to use reliable contraception
- able to give fully informed written consent.
Who cannot join
- Pregnant or lactating woman, or sexually active woman of child-bearing potential not using reliable contraception
- Clinically relevant abnormal findings at the screening assessment
- Clinically significant vital signs outside the acceptable range at screening
- Clinically relevant abnormal medical history, surgery or concurrent medical condition
- Acute or chronic illness
- Estimated glomerular filtration rate less than 80 mL/min/1.73 m2
Show all 14Show fewer
- Severe adverse reaction to any drug or sensitivity to the trial medication or its components
- Significant food allergy; vegetarian or vegan
- Participation in other clinical trials of unlicensed or prescription medicines, or loss of more than 400 mL blood, within the 3 months before first dose of trial medication
- Drug or alcohol abuse
- Smoking of more than 5 cigarettes daily
- Possibility that subject will not cooperate
- Positive test for hepatitis B \& C, HIV
- Objection by a General Practitioner
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Open-label, One-sequence Study to Assess the Effect of Repeated Oral Doses of Cimetidine on the Single Dose Pharmacokinetics, Safety and Tolerability of Imeglimin in Healthy Caucasian Subjects
The trial is an open-label assessment of the interaction of imeglimin with cimetidine. Up to 16 healthy men and women will receive a single oral dose of 1,500 mg imeglimin alone followed by a second dose of imeglimin during repeated doses of 400 mg cimetidine taken twice daily for 6 days.
- Conditions
- Healthy
- Being tested
- Imeglimin, Cimetidine
- Keywords
- pharmacokinetics, Drug-drug interaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ImegliminDrug
2 singles oral doses of imeglimin 1,500 mg (one at day 1 and one at day 8)
CimetidineDrug
400 mg of cimetidine bid from Day 5 to Day 10
| Study group | Role | What they receive |
|---|---|---|
| Open-label imeglimin + cimetidine | Experimental | Day 1: single oral dose of 1,500 mg imeglimin Day 5 to Day 10 inclusive: repeated doses of 400 mg cimetidine twice daily Day 8: second 1,500 mg dose of imeglimin together with the morning dose of cimetidine Receives: Drug: Imeglimin; Drug: Cimetidine |
What is being measured
The primary outcome is the main question the study is designed to answer.
PK parameters of imeglimin
Cmax: peak plasma concentration after dosing
Measured: At Day 1
Secondary outcomes (2)
PK parameters of imeglimin
AUC last:area under the concentration-time curve
Measured: From day 1 to day 3
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Incidence of Treatment-Emergent Adverse Events
Measured: from day 1 to day 17
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2018
- Study start19 Jun 2018
- Primary completion21 Jul 2018
- Study completion27 Jul 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Poxel SA
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03618316
- Sponsor's protocol ID
- PXL008-023
- Status last verified
- Aug 2018
- First submitted
- 8 Jun 2018
- Last updated
- 27 Aug 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, One-sequence Study to Assess the Effect of Repeated Oral Doses of Cimetidine on the Single Dose Pharmacokinetics, Safety and Tolerability of Imeglimin in Healthy Caucasian Subjects
- ClinicalTrials.gov ID
- NCT03618316
- Acronym / sponsor ID
- PXL008-023
- Conditions
- Healthy
- Keywords
- pharmacokinetics, Drug-drug interaction
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Poxel SAIndustry (pharma, biotech, devices)
- Study start
- 19 Jun 2018 (actual)
- Primary completion
- 21 Jul 2018 (actual)
- Study completion
- 27 Jul 2018 (actual)
- First posted
- 7 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The trial is an open-label assessment of the interaction of imeglimin with cimetidine. Up to 16 healthy men and women will receive a single oral dose of 1,500 mg imeglimin alone followed by a second dose of imeglimin during repeated doses of 400 mg cimetidine taken twice daily for 6 days.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Open-label imeglimin + cimetidine | Experimental | Drug: Imeglimin, Drug: CimetidineDay 1: single oral dose of 1,500 mg imeglimin Day 5 to Day 10 inclusive: repeated doses of 400 mg cimetidine twice daily Day 8: second 1,500 mg dose of imeglimin together with the morning dose of cimetidine |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- BMI : 18.5-29.9
- Body weight ≥ 60 kg
- willing to use reliable contraception
- able to give fully informed written consent.
Key exclusion criteria (14 listed)
- Pregnant or lactating woman, or sexually active woman of child-bearing potential not using reliable contraception
- Clinically relevant abnormal findings at the screening assessment
- Clinically significant vital signs outside the acceptable range at screening
- Clinically relevant abnormal medical history, surgery or concurrent medical condition
- Acute or chronic illness
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 |
|---|---|---|
| Imeglimin2 singles oral doses of imeglimin 1,500 mg (one at day 1 and one at day 8) | Drug | Open-label imeglimin + cimetidine |
| Cimetidine400 mg of cimetidine bid from Day 5 to Day 10 | Drug | Open-label imeglimin + cimetidine |
Primary outcome
PK parameters of imeglimin
Time frame: At Day 1
Cmax: peak plasma concentration after dosing
2 secondary outcomes
PK parameters of imeglimin
Time frame: From day 1 to day 3
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Time frame: from day 1 to day 17
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 27 Aug 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Imeglimin and Cimetidine in people with Healthy, run by Poxel SA 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 14 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 27 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. 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?
PK parameters of imeglimin (time frame: At Day 1). 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 27 Aug 2018.