Healthy Volunteer Clinical Trial
Official title:
Phase I Study of ASP015K: Single-Dose and Multiple-Dose Oral Administration in Healthy Nonelderly Men
Verified date | September 2019 |
Source | Astellas Pharma Inc |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
A study to evaluate the safety, tolerability and PK profiles of single and multiple doses of ASP015K in healthy nonelderly men.
Status | Completed |
Enrollment | 72 |
Est. completion date | March 10, 2010 |
Est. primary completion date | March 10, 2010 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Male |
Age group | 20 Years to 44 Years |
Eligibility |
Inclusion Criteria: - Healthy judged by the investigator or subinvestigator on the basis of physical examination and all test results - Weight - Japanese: = 50.0 kg to < 80.0 kg - Caucasians: = 50.0 kg to < 100.0 kg - BMI - Japanese: = 17.6 kg/m2 to < 26.4 kg/m2 - Caucasians: = 18.0 kg/m2 to < 30.0 kg/m2 - Written informed consent obtained from the subject personally Exclusion Criteria: - Administered drug in another clinical study or a post-market clinical study in the 120 days prior to the study - Collection of 400 mL of whole blood within 90 days prior to the study, 200 mL of whole blood within 30 days prior to the study or blood components within 14 days prior to the study - Received or is scheduled to receive drug treatment within 7 days prior to the drug administration - A history of drug allergies - Upper gastrointestinal symptoms, e.g., nausea, vomiting or stomachache, within 7 days prior to the drug admission - Concurrent or previous liver disease, e.g., viral hepatitis or drug-induced hepatic injury - Concurrent or previous heart disease, e.g., congestive heart failure, angina pectoris or arrhythmias requiring treatment - Concurrent or previous kidney disease, e.g., acute renal failure, glomerulonephritis or interstitial nephritis (except for previous urinary calculus) - Concurrent or previous cerebrovascular disease, e.g., cerebral infarction - Concurrent or previous malignancy - Concurrent or previous active or recurrent infection, e.g., hepatitis B, hepatitis C or syphilis |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Astellas Pharma Inc |
Japan,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Safety evaluated by the incidence of AE, vital signs , standard 12-lead ECG and Laboratory tests | For 48 hours after administration | ||
Secondary | Plasma unchanged drug concentration | For 48 hours after administration | ||
Secondary | Urinary unchanged drug concentration | For 48 hours after administration | ||
Secondary | Transcription factor phosphorylation level | For 48 hours after administration |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT06326723 -
Investigate the PK, Safety, and Tolerability After Single and Multiple Dose Daridorexant in Chinese Healthy Subjects
|
Phase 1 | |
Recruiting |
NCT00001367 -
Diagnosis and History Study of Patients With Different Neurological Conditions
|
||
Completed |
NCT02699710 -
Effect of Food, Rabeprazole, Methotrexate and Formulation on the Pharmacokinetics (PK) of GDC-0853 and the Effect of GDC-0853 on the PK of Methotrexate in Healthy Subjects
|
Phase 1 | |
Completed |
NCT02231892 -
Repetitive Transcranial Magnetic Stimulation Equipment Testing and Pilot Study
|
N/A | |
Not yet recruiting |
NCT06441916 -
Bioequivalence Study of Dabigatran Etexilate Capsules 150 mg in Healthy Thai Volunteers Under Fasting Conditions
|
Phase 1 | |
Completed |
NCT03771586 -
A Study to Assess the Electrophysiology, Safety, Tolerability, and Pharmacokinetics of SAGE-718 Using a Ketamine Challenge in Healthy Subjects
|
Phase 1 | |
Not yet recruiting |
NCT06337422 -
Bioequivalence Study of Generic Celecoxib 200 mg Capsules
|
Phase 1 | |
Completed |
NCT03302182 -
Bioequivalence Study of Ritonavir Versus NORVIR in Healthy Chinese Subjects
|
Phase 1 | |
Completed |
NCT05049343 -
Study of SAGE-904 Using a Ketamine Challenge to Evaluate Electrophysiology, Safety, Tolerability, and Pharmacokinetics in Healthy Participants
|
Phase 1 | |
Recruiting |
NCT01629108 -
Normal Values in Hearing and Balance Testing
|
||
Completed |
NCT02947854 -
Study to Assess Safety, Tolerability and Immune Response of Fimaporfin-induced Photochemical Internalisation of Antigen/Adjuvant
|
Phase 1 | |
Completed |
NCT02534870 -
Pharmacokinetics and Safety of the Co-administration of ABT-450/Ritonavir/ABT-267 (ABT-450/r/ABT-267) and ABT-333 in Healthy Chinese Subjects
|
Phase 1 | |
Completed |
NCT02224053 -
Drug-Drug Interaction Study With AZD9291 and Omeprazole in Healthy Volunteers
|
Phase 1 | |
Completed |
NCT01697436 -
A Bioequivalence Study of an Oral Solution of Copegus (Ribavirin) Compared to Copegus Tablets
|
Phase 1 | |
Completed |
NCT01676584 -
A Study of Single Dose RO6811135 in Healthy Volunteers
|
Phase 1 | |
Completed |
NCT01684891 -
A 28-Day Pharmacokinetics Study of RG1662 in Healthy Male Volunteers
|
Phase 1 | |
Completed |
NCT01711762 -
A Pharmacokinetics Study of Radioactive-Labeled GDC-0973 in Healthy Male Volunteers
|
Phase 1 | |
Completed |
NCT01433575 -
A Pharmacokinetic Study of RO4917838 in Healthy Chinese Volunteers
|
Phase 1 | |
Completed |
NCT01461967 -
A Study on Safety, Pharmacokinetics and Pharmacodynamics of RO5508887 in Healthy Volunteers
|
Phase 1 | |
Completed |
NCT01591850 -
A Drug-Drug Interaction Study of Ketoconazole, Rifampicin and Ritonavir-Boosted Atazanavir With Single-Dose RO5093151 in Healthy Volunteers
|
Phase 1 |