A Phase 1 interventional study of KW-6356 and Clarithromycin in Parkinson's Disease, sponsored by Kyowa Kirin Co., Ltd.. Completed at 1 site in Japan. Open to male participants aged 20 Years to 44 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-11-29.
Sponsored by Kyowa Kirin Co., Ltd. · Phase 1, Interventional, and Treatment
The purpose of this study is to investigate the effects of CYP3A4/5 inhibitor or inducer on the pharmacokinetics of KW-6356 when CYP3A4/5 inhibitor or inducer is orally administered to healthy Japanese men for 7 days.
4,484 studies on the registry are indexed under Parkinson Disease; 1,081 are open to participants now.
This study's enrollment of 20 is below the median of 40 across 3,293 interventional studies indexed under Parkinson Disease.
Browse Parkinson Disease studies →Kyowa Kirin Co., Ltd. is the lead sponsor of 155 studies on the registry; 10 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Drug: KW-6356 · Drug: Clarithromycin
Drug: KW-6356 · Drug: Rifampicin
A single oral dose will be administered at Day 1 and 15
400mg, oral tablet (2 x 200mg), twice daily (BID), Day 8-28
600mg, oral tablet (4 x 150mg), once daily (QD), Day 8-21
Geometric mean ratio of the pharmacokinetic parameter (AUC0-t) of KW-6356 in combination with or without a perpetrator drug
Time frame: Starting just before intake of KW-6356 and continued until 168 or 336 hours after intake of KW-6356.
Geometric mean ratio of the major pharmacokinetic parameters (Cmax) of KW-6356 in combination with or without a perpetrator drug
Time frame: Starting just before intake of KW-6356 and continued until 168 or 336 hours after intake of KW-6356.
Geometric mean ratio of the major pharmacokinetic parameters (AUC0-∞) of KW-6356 in combination with or without a perpetrator drug
Time frame: Starting just before intake of KW-6356 and continued until 168 or 336 hours after intake of KW-6356.
Pharmacokinetic parameters (tmax) of KW-6356
Time frame: Starting just before intake of KW-6356 and continued until 168 or 336 hours after intake of KW-6356.
Pharmacokinetic parameters (CL/F) of KW-6356
Time frame: Starting just before intake of KW-6356 and continued until 168 or 336 hours after intake of KW-6356.
Pharmacokinetic parameters (Vz/F) of KW-6356
Time frame: Starting just before intake of KW-6356 and continued until 168 or 336 hours after intake of KW-6356.
Pharmacokinetic parameters (t1/2) of KW-6356
Time frame: Starting just before intake of KW-6356 and continued until 168 or 336 hours after intake of KW-6356.
Plasma concentrations of a perpetrator drug
Time frame: Starting just before intake of a perpetrator drug at Day 8 and continued until 12 or 24 hours after the last dose of a perpetrator drug.
Incidence of treatment-emergent adverse events
Time frame: Starting 24 hours before intake of KW-6356 and continued until 14 days after the last dose of a perpetrator drug.
Plan to share: Undecided
No publications or documents are linked to this record.
This study is completed, as verified in Nov 2019. You cannot join it, but the record below documents what was studied.
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Kyowa Kirin Co., Ltd.