A Phase 1, Randomized, Single-Center Study to Investigate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single and Multiple Doses of R948835 in Healthy Subjects

Completed

• Conditions: Inflammatory conditions; autoimmuun and inflammatory conditions; 10003816

• Registration Number: NL-OMON48536
• Lead Sponsor: Rigel Pharmaceuticals, Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 2019-12-05
• Last Update Posted: 15 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 88

Inclusion Criteria

Healthy male and females (18 till 55 years including)

Exclusion Criteria

Clinical significant abnormalities at medical research

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Part A<br /><br>* Safety and tolerability parameters include: physical examination, AEs,<br /><br>clinical laboratory values, vital signs, and 12-lead ECG.<br /><br>Part B<br /><br>* Safety and tolerability parameters include: physical examination, AEs,<br /><br>clinical laboratory values, vital signs, and 12-lead ECG.<br /><br>Part C<br /><br>* Pharmacodynamic parameters include: AUEC, Cmax and tmax of CRP, TNF-*, IL-6,<br /><br>IL-8 , MIP1a and MIP1b over 24 hours after LPS challenge.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Part A<br /><br>* Pharmacokinetic parameters include: Cmax, tmax, t1/2, AUC0-t, AUC0-*, Cavg,<br /><br>CL/F, and Vz/F.<br /><br>Part B<br /><br>* Pharmacokinetic parameters include: Cmax, tmax, t1/2, AUC0-t, AUC0-*,<br /><br>AUC0-tau, Cavg, CL/F, and Vz/F.<br /><br>* Pharmacokinetic parameters for caffeine (Cohort B2 only): Cmax, tmax, t1/2,<br /><br>AUC0-t, and AUC0-*.<br /><br>Part C<br /><br>* Pharmacokinetic parameters include: Cmax, tmax, t1/2, AUC0-t, AUC0-*, Cavg,<br /><br>CL/F, and Vz/F.</p><br>