Healthy Subject Clinical Trial
Official title:
A Clinical Pharmacology Study of RTA 402 (Investigation of the Effect of Food on the Pharmacokinetics of RTA 402 Capsules in Japanese Healthy Adults and Comparison of the Pharmacokinetics With Those in Caucasian Healthy Adults)
Verified date | February 2020 |
Source | Kyowa Kirin Co., Ltd. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Food effect part:
To investigate the effect of food on the pharmacokinetics of RTA 402 and evaluate the safety
of RTA 402 in Japanese healthy male adults, using the capsule formulations.
Caucasian subject part:
To investigate the pharmacokinetics of a single dose of RTA 402 administered in the fasted
state and compare the pharmacokinetics with those observed in Japanese healthy male adults in
the food effect part
Status | Completed |
Enrollment | 36 |
Est. completion date | June 14, 2019 |
Est. primary completion date | June 14, 2019 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Male |
Age group | 20 Years to 39 Years |
Eligibility |
Inclusion Criteria: 1) Written voluntary informed consent to participate in the study; 2) [Food Effect Part] Japanese men 20 to <40 years of age at informed consent; [Caucasian Subject Part] Caucasian men 20 to <40 years of age at informed consent; 3) BMI 18.5 kg/m2 to <25.0 kg/m2 at screening Exclusion Criteria: 1. Presence of any disease requiring treatment; 2. History of heart failure (e.g., history of diagnosis of congestive heart failure categorized as Class III or IV of the New York Heart Association (NYHA) Functional Classification or history of hospitalization due to heart failure); 3. Alcoholism or drug addiction, or any positive result on drug abuse testing; 4. History of or current drug allergy; 5. Any positive result on infectious disease testing. Individuals who are positive for active antibodies produced by hepatitis B vaccination and are not infected with hepatitis B virus at screening can be enrolled in the study; |
Country | Name | City | State |
---|---|---|---|
Japan | Medical Corporation Heishinkai OPHAC Hospital | Osaka |
Lead Sponsor | Collaborator |
---|---|
Kyowa Kirin Co., Ltd. |
Japan,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Cmax | Pre-dose, 0.5, 1, 2, 4, 6, 8, 10, 12, 24, 30, 36, 48, 60, 72, 96 hours | ||
Primary | AUC0-t | Pre-dose, 0.5, 1, 2, 4, 6, 8, 10, 12, 24, 30, 36, 48, 60, 72, 96 hours | ||
Secondary | tmax | Pre-dose, 0.5, 1, 2, 4, 6, 8, 10, 12, 24, 30, 36, 48, 60, 72, 96 hours | ||
Secondary | AUC0-8 | Pre-dose, 0.5, 1, 2, 4, 6, 8, 10, 12, 24, 30, 36, 48, 60, 72, 96 hours | ||
Secondary | t1/2 | Pre-dose, 0.5, 1, 2, 4, 6, 8, 10, 12, 24, 30, 36, 48, 60, 72, 96 hours | ||
Secondary | MRT | Pre-dose, 0.5, 1, 2, 4, 6, 8, 10, 12, 24, 30, 36, 48, 60, 72, 96 hours | ||
Secondary | kel | Pre-dose, 0.5, 1, 2, 4, 6, 8, 10, 12, 24, 30, 36, 48, 60, 72, 96 hours |
Status | Clinical Trial | Phase | |
---|---|---|---|
Active, not recruiting |
NCT02664883 -
Myeloid Derived Suppressor Cells Clinical Assay in Finding Kidney Cancer
|
||
Completed |
NCT05611281 -
GS3-007a Oral Solution in Healthy Subjects
|
Phase 1 | |
Completed |
NCT03457480 -
Text Messages in Preventing Tobacco Use in Young Adults
|
N/A | |
Completed |
NCT05358756 -
A Study of Bioavailability and Food Effect of SACT-1 and Edurant® Tablets in Healthy Adult Volunteers
|
Phase 1 | |
Completed |
NCT06037395 -
Phase I Study to Compare the Pharmacokinetics, Pharmacodynamics, and Safety Between CT-P41 and US-licensed Prolia in Healthy Male Subjects
|
Phase 1 | |
Active, not recruiting |
NCT04032106 -
HPV Vaccine Intervention for Young Sexual Minority Men
|
N/A | |
Completed |
NCT04062955 -
Effects of Alternative Healthy Eating Index-Based Diet on Inflammatory Markers and Breast Density in Healthy Participants
|
N/A | |
Recruiting |
NCT03897270 -
Photoacoustic Imaging of the Breast in Patients With Breast Cancer and Healthy Subjects
|
N/A | |
Completed |
NCT01846520 -
Family Caregiver Palliative Care Intervention in Supporting Caregivers of Patients With Stage II-IV Gastrointestinal, Gynecologic, Urologic and Lung Cancers
|
N/A | |
Completed |
NCT02960100 -
mHealth Intervention in Increasing HPV Vaccinations in College Students
|
N/A | |
Completed |
NCT03698318 -
Pharmacokinetics Assessing Bioavailability of Gingerols and Shogaols of Five Ginger Extracts
|
N/A | |
Completed |
NCT05497635 -
A Study of STSA-1002 in Healthy Subjects
|
Phase 1 | |
Active, not recruiting |
NCT03303846 -
Combined Breast MRI and Biomarker Strategies in Identifying High-risk Breast Cancer Patients
|
N/A | |
Terminated |
NCT05559125 -
A Study of STSA-1002 Combined With STSA-1005 in Healthy Subjects
|
Phase 1 | |
Completed |
NCT03584100 -
Effect of Pneumatic Tourniquet on Arm Swelling After Lymph Node Removal
|
N/A | |
Recruiting |
NCT05117385 -
The Effect of the Consumption of 4 Botanical Extracts on Immunity in Healthy Adults (B-4-Immune)
|
N/A | |
Active, not recruiting |
NCT05660720 -
Evaluate the Effect of Orelabrutinib on Cardiac Repolarization in Healthy Subjects
|
Phase 1 | |
Recruiting |
NCT03188848 -
Dose Escalating Study of BPI-3016 in Healthy Subjects
|
Phase 1 | |
Completed |
NCT01908920 -
Osteopathic Manipulative Treatment Effects on High Frequency Parameters in Healthy Subjects
|
N/A | |
Active, not recruiting |
NCT03491176 -
Magnetic Resonance (MR) Imaging & Blood Biomarkers for Head and Neck Cancer
|
N/A |