A Phase I Study to Assess the Effect of Itraconazole and Rifampicin on Pharmacokinetics Profile of BPI-7711
Study Details
Study Description
Brief Summary
This is a phase I study to assess the effect of itraconazole and rifampicin on the pharmacokinetic parameters of BPI-7711 in Chinese healthy volunteers.
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
Phase 1 |
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
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Experimental: Itraconazole and BPI-7711 BPI-7711 alone followed by BPI-7711 +Itraconazole, followed by Itraconazole alone. |
Drug: BPI-7711
BPI-7711 60 mg
Other Names:
Drug: Itraconazole
Itraconazole 200 mg
Other Names:
|
Experimental: Rifampicin and BPI-7711 BPI-7711 alone followed by BPI-7711 +Rifampicin, followed by Rifampicin alone. |
Drug: BPI-7711
BPI-7711 180 mg
Other Names:
Drug: Rifampicin
Rifampicin 600 mg
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Cmax [Blood samples collected on Day 1 and Day 20 (arm 1)/Day 25 (arm 2) at pre-dose, 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48, 72, 96, 120, 144, 168 and 336 hours post BPI-7711 dose]
Pharmacokinetics of BPI-7711 by assessment of maximum plasma concentration
- AUC(0-last) [Blood samples collected on Day 1 and Day 20 (arm 1)/Day 25 (arm 2) at pre-dose, 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48, 72, 96, 120, 144, 168 and 336 hours post BPI-7711 dose]
Pharmacokinetics of BPI-7711 by assessment of area under the plasma concentration time curve from zero to last assessed timepoint
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Male, aged from 18 to 45 years
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BMI from 18.5 to 28.0 kg/m2
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Medical history, vital signs, physical examination and lab tests are normal or abnormal without clinical significance
Exclusion Criteria:
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Subjects with clinical significant diseases
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Subjects with allergic disease history
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Subjects with gastrointestinal disease history that can affect study drug absorption
-
Subjects with drug abuse history
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | Shanghai Xuhui Central Hospital | Shanghai | China | 200000 |
Sponsors and Collaborators
- Beta Pharma, Inc.
Investigators
- Principal Investigator: Jingying Jia, Shanghai Xuhui Central Hospital
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- BPI-7711DDI