Drug-Drug Interaction (DDI)Phase 1NCT01797198
A Study to Assess the Effect of Multiple Doses of Gemfribozil on a Single Dose of ASP3652, and to Assess the Effects of Multiple Doses of ASP3652 on a Single Dose of Repaglinide in the Body of Healthy Subjects
A Phase 1 study testing ASP3652, Gemfibrozil and Repaglinide in people with Drug-Drug Interaction (DDI) and Healthy Subjects, run by Astellas Pharma Europe B.V. at 1 site in United Kingdom.
Trial summary
ASP3652 is being investigated as a novel treatment for chronic pelvic pain. This is a two-part study to investigate the drug-drug potential of ASP3652. Part I of the study evaluates the effect of gemfibrozil twice daily on the single dose of ASP3652. Read more about this study
- Who is it for?
- Ages 18 to 55 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Drug-Drug Interaction (DDI), Healthy Subjects
- What is being tested?
- ASP3652, Gemfibrozil and Repaglinide
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Apr 2012to Jun 2012
- 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
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Subject is white and of Caucasian origin.
- Body Mass Index more than or equal to 18.5 and less than 30.0 kg/m2.
- Male subjects must agree to practice an effective contraceptive method with female sexual partners to prevent pregnancy.
Who cannot join
- Known or suspected hypersensitivity to ASP3652, repaglinide and/or gemfibrozil, or any components of the formulation used.
- Any of the liver function tests (ALT, AST, γ-GT, TBL and ALP) above the upper limit of normal. In such case the sample may be repeated once.
- Regular use of any inducer of metabolism (e.g. barbiturates, Rifampicin) in the 3 months prior to admission to the Clinical Unit.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Open Label, Drug-drug Interaction Study to Assess the Effect of Multiple Doses of Gemfibrozil on the Single Dose Pharmacokinetics of ASP3652 and to Assess the Effect of Multiple Doses of ASP3652 on the Single Dose Pharmacokinetics of Repaglinide
ASP3652 is being investigated as a novel treatment for chronic pelvic pain. This is a two-part study to investigate the drug-drug potential of ASP3652.
Part I of the study evaluates the effect of gemfibrozil twice daily on the single dose of ASP3652.
Part 2 evaluates the effect of multiple doses of ASP3652 twice daily on the single dose of repaglinide.
Subjects participating in one part of the study may not participate in the other part.
Read the detailed description
Part 1:
On Day 1, a single dose of ASP3652 is administered. After a wash-out period of 3 days, bid (twice daily) dosing of gemfibrozil starts on Day 4 and continues for 7 days until Day 10. On Day 8 (the 5th day of gemfibrozil administration), a single dose of ASP3652 is administered one hour after the morning dose of gemfibrozil.
Part 2:
On Day 1, a single dose of repaglinide is administered. After a wash-out period of 3 days, bid dosing of ASP3652 starts on Day 4 and continues for 7 days until Day 10. On Day 8 (the 5th day of ASP3652 administration), a single dose of repaglinide is administered one hour after the morning dose of ASP3652.
- Conditions
- Drug-Drug Interaction (DDI), Healthy Subjects
- Being tested
- ASP3652, Gemfibrozil, Repaglinide
- Keywords
- Phase I, ASP3652, Gemfibrozil, Repaglinide, Pharmacokinetics
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ASP3652Drug
Oral
GemfibrozilDrug
Oral
RepaglinideDrug
Oral
| Study group | Role | What they receive |
|---|---|---|
| gemfibrozil + ASP3652 | Experimental | Multiple doses of gemfibrozil and single dose of ASP3652 Receives: Drug: ASP3652; Drug: Gemfibrozil |
| ASP3652 + repaglinide | Experimental | Multiple doses of ASP3652 and the single dose of repaglinide Receives: Drug: ASP3652; Drug: Repaglinide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effect of multiple doses of gemfibrozil on the Pharmacokinetics (PK) of a single dose of ASP3652 (plasma) and metabolites H1/H2/H3
Part 1: Maximum concentration (Cmax), AUClast and AUCinf
Measured: Days 1 - 11
Effect of multiple doses of ASP3652 on the PK of a single dose of repaglinide and metabolite M4 (plasma)
Part 2: Cmax, AUClast, AUCinf, and the ratio AUC(M4) / AUC(repaglinide)
Measured: Days 1 - 10
Assess the safety of single and multiple doses of ASP3652 alone and in combination with gemfibrozil or repaglinide
Both Parts: Vital signs, physical examination, adverse events, electrocardiogram, clinical laboratory assessments, body temperature, Bond and Lader Visual Analogue Scale (VAS) questionnaire, Physician's Withdrawal Checklist (PWC)
Measured: Screening - End of Study Visit (7-14 days after (early) discharge)
Secondary outcomes (3)
Effect of multiple doses of gemfibrozil on the PK of a single dose of ASP3652 (plasma), metabolites H1/H2/H3 and Parent gemfibrozil and gemfibrozil-1-O-ß-glucuronide (plasma)
Part 1: tmax, tlag, t1/2, Vz/F, CL/F, Cmax, morning and evening Ctrough, tmax, AUCtau and CL/F
Measured: Days 1-11
Effect of multiple doses of ASP3652 on the PK of a single dose of repaglinide
Part 2: tmax, tlag, t1/2, Vz/F, CL/F, Cmax, morning and evening Ctrough, tmax, AUCtau and CL/F
Measured: Days 1-10
Effect of ASP3652 on the Pharmacodynamics (PD) of repaglinide by comparing the effect of repaglinide on blood glucose levels in the presence and absence of ASP3652
Part 2: Baseline blood glucose concentration, minimum blood glucose concentration, and mean blood glucose concentration from 0 to 9h after dosing of repaglinide
Measured: Days 1-10
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Feb 2013 (estimated)
- Study startApr 2012
- Primary completionJun 2012
- Study completionJun 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Drug-Drug Interaction (DDI)Studies 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
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Astellas Pharma Europe B.V.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Study Manager, Study chair, Astellas Pharma Europe B.V.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01797198
- Sponsor's protocol ID
- 3652-CL-0006
- Other IDs
- 2011-002874-21
- Status last verified
- Feb 2013
- First submitted
- 20 Feb 2013
- Last updated
- 22 Feb 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Feb 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open Label, Drug-drug Interaction Study to Assess the Effect of Multiple Doses of Gemfibrozil on the Single Dose Pharmacokinetics of ASP3652 and to Assess the Effect of Multiple Doses of ASP3652 on the Single Dose Pharmacokinetics of Repaglinide
- ClinicalTrials.gov ID
- NCT01797198
- Acronym / sponsor ID
- 3652-CL-0006
- Conditions
- Drug-Drug Interaction (DDI), Healthy Subjects
- Keywords
- Phase I, ASP3652, Gemfibrozil, Repaglinide, Pharmacokinetics
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Astellas Pharma Europe B.V.Industry (pharma, biotech, devices)
- Study start
- Apr 2012
- Primary completion
- Jun 2012 (actual)
- Study completion
- Jun 2012 (actual)
- First posted
- 22 Feb 2013 (estimated)
- 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.
ASP3652 is being investigated as a novel treatment for chronic pelvic pain. This is a two-part study to investigate the drug-drug potential of ASP3652.
Part I of the study evaluates the effect of gemfibrozil twice daily on the single dose of ASP3652.
Part 2 evaluates the effect of multiple doses of ASP3652 twice daily on the single dose of repaglinide.
Subjects participating in one part of the study may not participate in the other part.
Detailed description
Part 1:
On Day 1, a single dose of ASP3652 is administered. After a wash-out period of 3 days, bid (twice daily) dosing of gemfibrozil starts on Day 4 and continues for 7 days until Day 10. On Day 8 (the 5th day of gemfibrozil administration), a single dose of ASP3652 is administered one hour after the morning dose of gemfibrozil.
Part 2:
On Day 1, a single dose of repaglinide is administered. After a wash-out period of 3 days, bid dosing of ASP3652 starts on Day 4 and continues for 7 days until Day 10. On Day 8 (the 5th day of ASP3652 administration), a single dose of repaglinide is administered one hour after the morning dose of ASP3652.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| gemfibrozil + ASP3652 | Experimental | Drug: ASP3652, Drug: GemfibrozilMultiple doses of gemfibrozil and single dose of ASP3652 |
| ASP3652 + repaglinide | Experimental | Drug: ASP3652, Drug: RepaglinideMultiple doses of ASP3652 and the single dose of repaglinide |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Subject is white and of Caucasian origin.
- Body Mass Index more than or equal to 18.5 and less than 30.0 kg/m2.
- Male subjects must agree to practice an effective contraceptive method with female sexual partners to prevent pregnancy.
Key exclusion criteria (3 listed)
- Known or suspected hypersensitivity to ASP3652, repaglinide and/or gemfibrozil, or any components of the formulation used.
- Any of the liver function tests (ALT, AST, γ-GT, TBL and ALP) above the upper limit of normal. In such case the sample may be repeated once.
- Regular use of any inducer of metabolism (e.g. barbiturates, Rifampicin) in the 3 months prior to admission to the Clinical Unit.
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 |
|---|---|---|
| ASP3652Oral | Drug | ASP3652 + repaglinide, gemfibrozil + ASP3652 |
| GemfibrozilOral | Drug | gemfibrozil + ASP3652 |
| RepaglinideOral | Drug | ASP3652 + repaglinide |
Primary outcome
Effect of multiple doses of gemfibrozil on the Pharmacokinetics (PK) of a single dose of ASP3652 (plasma) and metabolites H1/H2/H3
Time frame: Days 1 - 11
Part 1: Maximum concentration (Cmax), AUClast and AUCinf
Effect of multiple doses of ASP3652 on the PK of a single dose of repaglinide and metabolite M4 (plasma)
Time frame: Days 1 - 10
Part 2: Cmax, AUClast, AUCinf, and the ratio AUC(M4) / AUC(repaglinide)
Assess the safety of single and multiple doses of ASP3652 alone and in combination with gemfibrozil or repaglinide
Time frame: Screening - End of Study Visit (7-14 days after (early) discharge)
Both Parts: Vital signs, physical examination, adverse events, electrocardiogram, clinical laboratory assessments, body temperature, Bond and Lader Visual Analogue Scale (VAS) questionnaire, Physician's Withdrawal Checklist (PWC)
3 secondary outcomes
Effect of multiple doses of gemfibrozil on the PK of a single dose of ASP3652 (plasma), metabolites H1/H2/H3 and Parent gemfibrozil and gemfibrozil-1-O-ß-glucuronide (plasma)
Time frame: Days 1-11
Effect of multiple doses of ASP3652 on the PK of a single dose of repaglinide
Time frame: Days 1-10
Effect of ASP3652 on the Pharmacodynamics (PD) of repaglinide by comparing the effect of repaglinide on blood glucose levels in the presence and absence of ASP3652
Time frame: Days 1-10
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 22 Feb 2013.
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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.
Study Manager study chair
Astellas Pharma Europe B.V.
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 ASP3652, Gemfibrozil and Repaglinide in people with Drug-Drug Interaction (DDI) and Healthy Subjects, run by Astellas Pharma Europe B.V. 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 3 inclusion and 3 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 22 Feb 2013. 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?
Effect of multiple doses of gemfibrozil on the Pharmacokinetics (PK) of a single dose of ASP3652 (plasma) and metabolites H1/H2/H3 (time frame: Days 1 - 11). The study lists 3 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 22 Feb 2013.