Primary objectives:Part A: To investigate the safety and tolerability of single ascending oral doses of R835 in healthy subjects.Part B:To investigate the safety and tolerability of multiple ascending oral doses of R835 in healthy subjects.Part C:…
ID
Source
Brief title
Condition
- Other condition
- Autoimmune disorders
Synonym
Health condition
Inflammatory conditions
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Part A
* Safety and tolerability parameters include: physical examination, AEs,
clinical laboratory values, vital signs, and 12-lead ECG.
Part B
* Safety and tolerability parameters include: physical examination, AEs,
clinical laboratory values, vital signs, and 12-lead ECG.
Part C
* Pharmacodynamic parameters include: AUEC, Cmax and tmax of CRP, TNF-*, IL-6,
IL-8 , MIP1a and MIP1b over 24 hours after LPS challenge.
Secondary outcome
Part A
* Pharmacokinetic parameters include: Cmax, tmax, t1/2, AUC0-t, AUC0-*, Cavg,
CL/F, and Vz/F.
Part B
* Pharmacokinetic parameters include: Cmax, tmax, t1/2, AUC0-t, AUC0-*,
AUC0-tau, Cavg, CL/F, and Vz/F.
* Pharmacokinetic parameters for caffeine (Cohort B2 only): Cmax, tmax, t1/2,
AUC0-t, and AUC0-*.
Part C
* Pharmacokinetic parameters include: Cmax, tmax, t1/2, AUC0-t, AUC0-*, Cavg,
CL/F, and Vz/F.
Background summary
Rigel Pharmaceuticals, Inc.is developing R948835 for the treatment of
autoimmuno and inflammatory conditions
Study objective
Primary objectives:
Part A: To investigate the safety and tolerability of single ascending oral
doses of R835 in healthy subjects.
Part B:To investigate the safety and tolerability of multiple ascending oral
doses of R835 in healthy subjects.
Part C: To characterize the pharmacodynamic (PD) profile of R835 following a
lipopolysaccharide (LPS) challenge in healthy subjects.
Secondary objectives:
Part A: To characterize the pharmacokinetic (PK) profiles of single oral doses
of R835 and its metabolite R941466.
Part B: To characterize the PK profiles of multiple oral doses of R835 and its
metabolite R941466.
Part B2: To evaluate the potential for R835-mediated inhibition of caffeine
metabolism, a CYP1A2 substrate.
Part C: To characterize the PK profiles of R835 following a LPS challenge.
Study design
This study is a randomized, double-blind, placebo-controlled Phase 1 study in
three parts: single ascending doses (Part A), multiple ascending doses (Part B)
with caffeine interaction on selected dose (Cohort B2 only), and single dose
with LPS challenge (Part C).
Intervention
R948835
Matching placebo
Study burden and risks
This study is being conducted in healthy volunteers. There are no anticipated
benefits of the IMP. Please see the IMP information (IB) for further
information.
1180 Veterans Blvd na
na 94080
US
1180 Veterans Blvd na
na 94080
US
Listed location countries
Age
Inclusion criteria
Healthy male and females (18 till 55 years including)
Exclusion criteria
Clinical significant abnormalities at medical research
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2018-000619-26-NL |
| CCMO | NL65180.056.18 |