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

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 - CS0292 (C-948835-001)

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON48536

Enrollment

Registered

2018-03-12

Start date

2018-04-19

Completion date

Unknown

Last updated

2024-04-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Inflammatory conditions autoimmuun and inflammatory conditions

Interventions

R948835 Matching placebo

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Healthy male and females (18 till 55 years including)

Exclusion criteria

Exclusion criteria: Clinical significant abnormalities at medical research

Design outcomes

Primary

Measure	Time frame
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.	—

Measure

Time frame

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

Measure	Time frame
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.	—

Measure

Time frame

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.

—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)