Site JP00001
Kagoshima, Japan
NCT Number: NCT02760342
The objective of this study is to evaluate the pharmacokinetic interactions between ASP015K and metformin in healthy non-elderly male subjects.
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Notify Me20 year–44 year
Male
Interventional
Phase 1
Kagoshima, Japan
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Oral
Other names: ASP015K
Oral
Time frame: Up to Day 12
AUCinf: Area under the concentration-time curve from the time of dosing extrapolated to time infinity
Time frame: Up to Day 12
Cmax: Maximum concentration
Time frame: Up to Day 12
AUClast: Area under the concentration-time curve from the time of dosing to the last measurable concentration
Time frame: Up to Day 12
CL/F: Apparent total systemic clearance
Time frame: Up to Day 12
t1/2: Terminal elimination half-life
Time frame: Up to Day 12
tmax: Time of Cmax
Time frame: Up to Day 12
Vz/F: Apparent volume of distribution during the terminal elimination phase
Time frame: Up to Day 12
Aelast: Amount of metformin excreted into the urine from the time of dosing to the last measurable concentration
Time frame: Up to Day 12
Aelast%: Percent of metformin excreted into the urine from the time of dosing to the last measurable concentration
Time frame: Up to Day 12
CLR: Renal clearance
Time frame: Up to Day 12
Time frame: Up to Day 12
Time frame: Up to Day 12
AUCtau: Area under the concentration-time curve from the time of dosing to the start of the next dosing interval
Time frame: Up to Day 12
Time frame: Up to Day 12
Time frame: Up to Day 12
Ctrough: Concentration immediately prior to dosing at multiple dosing
Time frame: Up to Day 12
PTR: Peak trough ratio
Time frame: Up to Day 12
Rac: accumulation ratio
Time frame: Up to Day 12
Time frame: Up to Day 12
Time frame: Up to Day 12
Time frame: Up to Day 12
Time frame: Up to Day 12
Time frame: Up to Day 12
Time frame: Up to Day 12
Time frame: Up to Day 12
Time frame: Up to Day 12
Time frame: Up to Day 12
Time frame: Up to Day 12
Time frame: Up to Day 12
Time frame: Up to 17 days after first study drug dosing
Time frame: Up to 17 days after first study drug dosing
Time frame: Up to 17 days after first study drug dosing
Time frame: Up to 17 days after first study drug dosing
ECG: Electrocardiogram
Astellas Pharma Inc
Industry
ASP015K Pharmacokinetic Study: Evaluation of Drug-Drug Interaction Between ASP015K and Metformin
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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