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NCT04023903
A Clinical Pharmacology Study of Bardoxolone Methyl in Healthy Adults
Phase 1 trial testing Bardoxolone methyl in Healthy Subject in 36 participants. Completed in 14 June 2019.
14 June 2019
Quick facts
| Lead sponsor | Kyowa Kirin Co., Ltd. |
|---|---|
| Phase | Phase 1 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | crossover |
| Masking | none |
| Primary purpose | other |
| Enrollment | 36 |
| Start date | 4 April 2019 |
| Primary completion | 14 June 2019 |
| Estimated completion | 14 June 2019 |
| Sites | 1 location across Japan |
Drugs / interventions tested
- Bardoxolone methyl — full drug profile →
- Bardoxolone methyl — full drug profile →
Conditions studied
- Healthy Subject — all drugs for Healthy Subject →
Sponsor
Kyowa Kirin Co., Ltd. — full company profile →
Who can join
Adults 20 to 39, male only, with Healthy Subject. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT04023903
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Bardoxolone methyl
Trials testing the same drug.
- NCT04018339 — A Study of RTA 402 in Obese Adults · Phase 1 · completed
- NCT03749447 — An Extended Access Program for Bardoxolone Methyl in Patients With CKD (EAGLE) · Phase 3 · terminated
- NCT03550443 — A Phase 3 Study of Bardoxolone Methyl in Patients With Diabetic Kidney Disease; AYAME Study · Phase 3 · terminated
- NCT03068130 — Extended Access Program to Assess Long-term Safety of Bardoxolone Methyl in Patients With Pulmonary Hypertension RANGER · Phase 3 · terminated
- NCT02036970 — Bardoxolone Methyl Evaluation in Patients With Pulmonary Hypertension (PH) - LARIAT · Phase 2 · completed
Other recruiting trials for Healthy Subject
Currently open trials in the same condition.
- NCT03897270 — Photoacoustic Imaging of the Breast in Patients With Breast Cancer and Healthy Subjects · NA · recruiting
- NCT03303846 — Combined Breast MRI and Biomarker Strategies in Identifying High-risk Breast Cancer Patients · NA · active not recruiting
- NCT03491176 — Magnetic Resonance (MR) Imaging & Blood Biomarkers for Head and Neck Cancer · active not recruiting
- NCT03207854 — Collection of Immunology Specimens From Patients With Cancer or Blood Disorders, and Healthy Volunteers · recruiting
- NCT03199365 — Tu Salud Si Cuenta Intervention in Increasing Physical Activity and Healthy Eating Among Latino Families · NA · active not recruiting
Other Kyowa Kirin Co., Ltd. trials
Trials by the same sponsor.
- NCT06926491 — Evaluate the Efficacy and Safety of KK8398 in Patients With Achondroplasia（AOBA Study） · Phase 3 · recruiting
- NCT06812104 — Clinical Trial of KK2845 in Patients With Relapsed or Refractory Acute Myeloid Leukemia · Phase 1 · recruiting
- NCT06525636 — A First-in-human Study of KK8123 in Adults With X-linked Hypophosphatemia · Phase 1, PHASE2 · recruiting
- NCT06116890 — Study to Assess the Efficacy & Safety of KHK4951 in Patients With Neovascular Age-Related Macular Degeneration · Phase 2 · active not recruiting
- NCT06116916 — Study to Assess the Efficacy & Safety of KHK4951 in Patients With Diabetic Macular Edema · Phase 2 · active not recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04023903 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Kyowa Kirin Co., Ltd.
- Last refreshed: 5 February 2020
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04023903.
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