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| ID | Type | Description | Link |
|---|---|---|---|
| 2011-002874-21 | EudraCT Number |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| gemfibrozil + ASP3652 | Experimental | Multiple doses of gemfibrozil and single dose of ASP3652 |
|
| ASP3652 + repaglinide | Experimental | Multiple doses of ASP3652 and the single dose of repaglinide |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ASP3652 | Drug | Oral |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 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) | 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) | Screening - End of Study Visit (7-14 days after (early) discharge) |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Days 1-11 |
| Effect of multiple doses of ASP3652 on the PK of a single dose of repaglinide |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Study Manager | Astellas Pharma Europe B.V. | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| PAREXEL Early Phase Clinical Unit | Harrow | HA1 3U | United Kingdom |
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| Gemfibrozil |
| Drug |
Oral |
|
| Repaglinide | Drug | Oral |
|
Part 2: tmax, tlag, t1/2, Vz/F, CL/F, Cmax, morning and evening Ctrough, tmax, AUCtau and CL/F |
| 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 | Days 1-10 |
| ID | Term |
|---|---|
| C000719587 | ASP3652 |
| D015248 | Gemfibrozil |
| C072379 | repaglinide |
| ID | Term |
|---|---|
| D058607 | Fibric Acids |
| D058610 | Isobutyrates |
| D002087 | Butyrates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
| D010421 | Pentanoic Acids |
| D014631 | Valerates |
| D010647 | Phenyl Ethers |
| D004987 | Ethers |
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D005232 | Fatty Acids, Volatile |
| D005227 | Fatty Acids |
| D008055 | Lipids |
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