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1 Trial |
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1 Trial |  |
3 News |  |
- | JNJ-61803534 / J&J
Preclinical, Journal: Preclinical and clinical characterization of the RORγt inhibitor JNJ-61803534. (Pubmed Central) - Nov 4, 2021
The compound was well tolerated in single ascending doses (SAD) up to 200 mg, and exhibited dose-dependent increases in exposure upon oral dosing, with a plasma half-life of 164 to 170 h. In addition, dose-dependent inhibition of ex vivo stimulated IL-17A production in whole blood was observed, demonstrating in vivo target engagement. In conclusion, JNJ-61803534 is a potent and selective RORγt inhibitor that exhibited acceptable preclinical safety and efficacy, as well as an acceptable safety profile in a healthy volunteer SAD study, with clear evidence of a pharmacodynamic effect in humans.
- | JNJ-61803534 / J&J
Enrollment change, Trial completion date, Trial termination, Trial primary completion date: A Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of JNJ-61803534 and to Evaluate the Effect of JNJ-61803534 on the Pharmacokinetics of Midazolam in Healthy Participants (clinicaltrials.gov) - Jul 20, 2018
P1, N=47, Terminated, Sponsor: Janssen Research & Development, LLC
In conclusion, JNJ-61803534 is a potent and selective RORγt inhibitor that exhibited acceptable preclinical safety and efficacy, as well as an acceptable safety profile in a healthy volunteer SAD study, with clear evidence of a pharmacodynamic effect in humans. N=124 --> 47 | Trial completion date: Jan 2019 --> Apr 2018 | Suspended --> Terminated | Trial primary completion date: Sep 2018 --> Apr 2018; Terminated due to nonclinical findings
- | JNJ-61803534 / J&J
Trial suspension: A Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of JNJ-61803534 and to Evaluate the Effect of JNJ-61803534 on the Pharmacokinetics of Midazolam in Healthy Participants (clinicaltrials.gov) - Apr 24, 2018
P1, N=124, Suspended, Sponsor: Janssen Research & Development, LLC
N=124 --> 47 | Trial completion date: Jan 2019 --> Apr 2018 | Suspended --> Terminated | Trial primary completion date: Sep 2018 --> Apr 2018; Terminated due to nonclinical findings Recruiting --> Suspended
- || JNJ-61803534 / J&J
Trial primary completion date: A Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of JNJ-61803534 and to Evaluate the Effect of JNJ-61803534 on the Pharmacokinetics of Midazolam in Healthy Participants (clinicaltrials.gov) - Nov 14, 2017
P1, N=124, Recruiting, Sponsor: Janssen Research & Development, LLC
Recruiting --> Suspended Trial primary completion date: Dec 2017 --> Sep 2018
- ||| JNJ-61803534 / J&J
Enrollment open: A Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of JNJ-61803534 and to Evaluate the Effect of JNJ-61803534 on the Pharmacokinetics of Midazolam in Healthy Participants (clinicaltrials.gov) - May 29, 2017
P1, N=108, Recruiting, Sponsor: Janssen Research & Development, LLC
Trial primary completion date: Dec 2017 --> Sep 2018 Not yet recruiting --> Recruiting
- ||| JNJ-61803534 / J&J
New P1 trial: A Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of JNJ-61803534 and to Evaluate the Effect of JNJ-61803534 on the Pharmacokinetics of Midazolam in Healthy Participants (clinicaltrials.gov) - May 4, 2017
P1, N=108, Not yet recruiting, Sponsor: Janssen Research & Development, LLC