33 completed. 25 Phase 1, 6 Phase 2, 2 Phase 3.
| Phase | Trials | Status |
|---|---|---|
| Phase 1 | 25 | Completed 25 |
| Phase 2 | 6 | Completed 6 |
| Phase 3 | 2 | Completed 2 |
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Tick up to 5 trials to compare them side by side (eligibility, arms, endpoints, adverse events) in a Literature Matrix.
| Trial | Phase | Status | Sponsor | Enrollment | Start | Updated |
|---|---|---|---|---|---|---|
| Study to Evaluate Multiple Doses of Fluconazole, a CYP3A4 and CYP2C9 Inhibitor, on the Pharmacokinetics of CTP-543 in Healthy Subjects CTP-543, Fluconazole - Health Volunteers | Phase 1 | Completed | Concert Pharmaceuticals | 18 | 2022-07-11 | 2022-08-30 |
| Study To Evaluate The Effect Of Multiple Doses of CTP-543 On The Pharmacokinetics Of Single Doses of Midazolam In Healthy Subjects Midazolam, CTP-543 - Health Volunteers | Phase 1 | Completed | Concert Pharmaceuticals | 20 | 2022-06-21 | 2022-07-20 |
| Study of the Effect of Food on the Bioavailability of the To-Be-Marketed Formulation of CTP-543 in Healthy Volunteers CTP-543 - Health Volunteers | Phase 1 | Completed | Concert Pharmaceuticals | 16 | 2022-06-14 | 2022-07-20 |
| Study to Assess the Effect of Renal Impairment on the Pharmacokinetics of CTP-543 CTP-543 - Renal Impairment | Phase 1 | Completed | Concert Pharmaceuticals | 16 | 2022-06-06 | 2022-11-29 |
| Study to Assess the Effect of Hepatic Impairment on the Pharmacokinetics of CTP-543 CTP-543 - Hepatic Impairment | Phase 1 | Completed | Concert Pharmaceuticals | 21 | 2022-06-01 | 2022-11-29 |
| A Randomized Study to Evaluate the Effects of CTP-543 on the QT/QTc Intervals in Health Volunteers CTP-543, Moxifloxacin, Placebo - Healthy Volunteers | Phase 1 | Completed | Concert Pharmaceuticals | 48 | 2022-01-04 | 2022-03-04 |
| Study to Evaluate the Efficacy and Safety of CTP-543 in Adults With Moderate to Severe Alopecia Areata (THRIVE-AA2) CTP-543 matching placebo, CTP-543 - Alopecia Areata | Phase 3 | Completed | Concert Pharmaceuticals | 517 | 2021-06-10 | 2023-07-03 |
| Drug-drug Interaction Study of CTP-543 and Rifampin in Healthy Adult Subjects CTP-543 - Healthy Volunteers | Phase 1 | Completed | Concert Pharmaceuticals | 22 | 2021-05-19 | 2021-07-20 |
| Drug-drug Interaction Study of CTP-543 and Itraconazole in Healthy Adult Subjects CTP-543 - Healthy Volunteers | Phase 1 | Completed | Concert Pharmaceuticals | 22 | 2021-03-02 | 2021-04-08 |
| A Study to Evaluate the Durability of Response of CTP-543 in Adult Patients With Moderate to Severe Alopecia Areata CTP-543, Placebo - Alopecia Areata | Phase 2 | Completed | Concert Pharmaceuticals | 317 | 2021-02-26 | 2024-10-09 |
| Study to Evaluate the Efficacy and Safety of CTP-543 in Adults With Moderate to Severe Alopecia Areata (THRIVE-AA1) CTP-543 matching placebo, CTP-543 - Alopecia Areata | Phase 3 | Completed | Concert Pharmaceuticals | 706 | 2020-11-23 | 2023-05-03 |
| Drug-drug Interaction Study of CTP-543 and Oral Contraceptives in Healthy Female Subjects CTP-543, Combined oral contraceptive containing Ethinyl estradiol (EE) and Levonorgestrel (LNG) - Healthy Volunteers | Phase 1 | Completed | Concert Pharmaceuticals | 21 | 2020-06-09 | 2020-07-16 |
| A Phase 2 Study to Evaluate the Safety and Efficacy of CTP-692 as an Adjunctive Treatment in Adults With Schizophrenia CTP-692, Placebo - Schizophrenia | Phase 2 | Completed | Concert Pharmaceuticals | 326 | 2019-11-26 | 2023-12-22 |
| Study Evaluating Pharmacokinetics and Mass Balance of [14C]-CTP-543 in Healthy Adult Male Volunteers [14C]-CTP-543 - Healthy Volunteers | Phase 1 | Completed | Concert Pharmaceuticals | 6 | 2019-09-05 | 2019-09-25 |
| Efficacy and Tolerability Study of Two Dosing Regimens of CTP-543 in Adults With Alopecia Areata CTP-543, CTP-543 Matching Placebo - Alopecia Areata | Phase 2 | Completed | Concert Pharmaceuticals | 66 | 2019-05-24 | 2023-04-05 |
| Multiple Ascending Dose Study of CTP-692 in Healthy Volunteers CTP-692 - Healthy | Phase 1 | Completed | Concert Pharmaceuticals | 30 | 2019-04-10 | 2019-06-13 |
| Food Effect Study of CTP-543 in Healthy Volunteers CTP-543 - Healthy | Phase 1 | Completed | Concert Pharmaceuticals | 14 | 2019-03-25 | 2019-06-13 |
| Efficacy and Tolerability Study of Two Dose Regimens of CTP-543 in Adults With Alopecia Areata CTP-543, CTP-543 Matching Placebo - Alopecia Areata | Phase 2 | Completed | Concert Pharmaceuticals | 57 | 2019-03-21 | 2022-12-09 |
| Study to Assess the Safety and Pharmacokinetic (PK) of CTP-692 in Healthy Volunteers CTP-692, Placebo - Healthy | Phase 1 | Completed | Concert Pharmaceuticals | 42 | 2019-01-24 | 2019-06-13 |
| A Study to Compare the Safety, Tolerability, and Pharmacokinetics of CTP-692 Versus D-serine in Healthy Volunteers CTP-692, D-Serine - Healthy Volunteers | Phase 1 | Completed | Concert Pharmaceuticals | 13 | 2018-12-14 | 2019-03-15 |
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Alopecia Areata (6) · Alopecia (2) · Hair Diseases (2) · Renal Insufficiency, Chronic (2) · Diabetes Mellitus, Type 2 (1) · Diabetic Nephropathies (1) · Disorders of Excessive Somnolence (1) · Narcolepsy (1) · Renal Insufficiency (1) · Schizophrenia (1)
1-(5-hydroxyhexyl)-3,7-dimethylxanthine (3) · ivacaftor (2) · Atazanavir Sulfate (1) · Fluconazole (1) · Levonorgestrel (1) · Midazolam (1) · Moxifloxacin (1) · Sodium Oxybate (1) · Tablets (1) · ruxolitinib (1)
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Lana Pilja (3) · Emily McIntyre (2) · Ginny Braman (2) · LuAnn Sabounjian (2) · Colleen E Hamilton, MS (1) · Colleen E. Hamilton (1) · Colleen Hamilton (1) · Gregory Tracey, MD (1) · James Shipley, MD (1) · Sepehr Shakib, MD (1)