Healthy Clinical Trial
Official title:
Clinical Pharmacology Study of FYU-981 for Subjects With Hepatic Insufficiency
Verified date | September 2018 |
Source | Mochida Pharmaceutical Company, Ltd. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The purpose of this study is to assess the pharmacokinetics, pharmacodynamics and safety after single oral administration of FYU-981 to subjects with hepatic insufficiency and with normal hepatic function.
Status | Completed |
Enrollment | 24 |
Est. completion date | June 25, 2018 |
Est. primary completion date | June 20, 2018 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 20 Years and older |
Eligibility |
Inclusion Criteria: - Adult healthy subjects or adult cirrhosis patients - Body mass index: >=18.5 and <30.0 Exclusion Criteria: - Subjects with any disease or any history of diseases that might be unsuitable for participation in the clinical study (except for cirrhosis patients with hepatic diseases) |
Country | Name | City | State |
---|---|---|---|
Japan | Mochida Investigational sites | Tokyo |
Lead Sponsor | Collaborator |
---|---|
Mochida Pharmaceutical Company, Ltd. | Fuji Yakuhin Co., Ltd. |
Japan,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Pharmacokinetics (Cmax: Maximum plasma concentration) | 48 hours | ||
Primary | Pharmacokinetics (Tmax: Time to reach the peak plasma concentration) | 48 hours | ||
Primary | Pharmacokinetics (T1/2: Elimination half-life of plasma concentration) | 48 hours | ||
Primary | Pharmacokinetics (AUC: Area under the plasma concentration-time curve) | 48 hours | ||
Primary | Pharmacokinetics (CLtot/F: Total clearance / Fraction of dose absorbed) | 48 hours | ||
Primary | Pharmacokinetics (kel: Elimination rate constant) | 48 hours | ||
Primary | Pharmacokinetics (Vd/F: Distribution volume / Fraction of dose absorbed) | 48 hours | ||
Primary | Pharmacokinetics (MRT: Mean residence time) | 48 hours | ||
Primary | Pharmacodynamics (Serum concentration of uric acid) | 48 hours | ||
Primary | Pharmacodynamics (Amount of uric acid excreted in urine) | 48 hours | ||
Primary | Safety (Incidence of treatment-emergent adverse events) | 192 hours |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT06052553 -
A Study of TopSpin360 Training Device
|
N/A | |
Completed |
NCT05511077 -
Biomarkers of Oat Product Intake: The BiOAT Marker Study
|
N/A | |
Recruiting |
NCT04632485 -
Early Detection of Vascular Dysfunction Using Biomarkers From Lagrangian Carotid Strain Imaging
|
||
Completed |
NCT05931237 -
Cranberry Flavan-3-ols Consumption and Gut Microbiota in Healthy Adults
|
N/A | |
Terminated |
NCT04556032 -
Effects of Ergothioneine on Cognition, Mood, and Sleep in Healthy Adult Men and Women
|
N/A | |
Completed |
NCT04527718 -
Study of the Safety, Tolerability and Pharmacokinetics of 611 in Adult Healthy Volunteers
|
Phase 1 | |
Completed |
NCT04065295 -
A Study to Test How Well Healthy Men Tolerate Different Doses of BI 1356225
|
Phase 1 | |
Completed |
NCT04107441 -
AX-8 Drug Safety, Tolerability and Plasma Levels in Healthy Subjects
|
Phase 1 | |
Completed |
NCT04998695 -
Health Effects of Consuming Olive Pomace Oil
|
N/A | |
Completed |
NCT01442831 -
Evaluate the Absorption, Metabolism, And Excretion Of Orally Administered [14C] TR 701 In Healthy Adult Male Subjects
|
Phase 1 | |
Terminated |
NCT05934942 -
A Study in Healthy Women to Test Whether BI 1358894 Influences the Amount of a Contraceptive in the Blood
|
Phase 1 | |
Recruiting |
NCT05525845 -
Studying the Hedonic and Homeostatic Regulation of Food Intake Using Functional MRI
|
N/A | |
Completed |
NCT05515328 -
A Study in Healthy Men to Test How BI 685509 is Processed in the Body
|
Phase 1 | |
Completed |
NCT04967157 -
Cognitive Effects of Citicoline on Attention in Healthy Men and Women
|
N/A | |
Completed |
NCT05030857 -
Drug-drug Interaction and Food-effect Study With GLPG4716 and Midazolam in Healthy Subjects
|
Phase 1 | |
Recruiting |
NCT04714294 -
Evaluate the Safety, Tolerability and Pharmacokinetics Characteristics of HPP737 in Healthy Volunteers
|
Phase 1 | |
Recruiting |
NCT04494269 -
A Study to Evaluate Pharmacokinetics and Safety of Tegoprazan in Subjects With Hepatic Impairment and Healthy Controls
|
Phase 1 | |
Completed |
NCT04539756 -
Writing Activities and Emotions
|
N/A | |
Recruiting |
NCT04098510 -
Concentration of MitoQ in Human Skeletal Muscle
|
N/A | |
Completed |
NCT03308110 -
Bioavailability and Food Effect Study of Two Formulations of PF-06650833
|
Phase 1 |