Safety, Pharmacokinetics and Pharmacodynamics of BIRB 796 BS Tablets Administered to Healthy Human Subjects
NCT02211157 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 24
Last updated 2014-08-08
Summary
Study to assess safety, pharmacokinetics and pharmacodynamics of BIRB 796 BS in escalating multiple doses with and without a 64 g fat breakfast at the 50 mg dose level
Conditions
- Healthy
Interventions
- DRUG
-
BIBR 796 BS
- DRUG
- OTHER
-
high fat breakfast
Sponsors & Collaborators
- lead INDUSTRY
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- DOUBLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 45 Years
- Sex
- MALE
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2000-03-31
- Primary Completion
- 2000-07-31
More Related Trials
-
Safety, Tolerability, and Pharmacokinetics of Single Rising Oral Doses of BIRB 1017 BS as a Solution in PEG 400 / 26% Ethanol Administered to Healthy Male Subjects
NCT02184338 ·Status: COMPLETED ·Phase: PHASE1
-
Excretion Balance of 14c-radiolabeled BIRB 796 BS in Normal Male Subjects
NCT02211885 ·Status: COMPLETED ·Phase: PHASE1
-
Safety, Tolerability and Pharmacokinetics of Oral BIBP 5371 CL in Healthy Male and Female Volunteers
NCT02256709 ·Status: COMPLETED ·Phase: PHASE1
-
Safety, Tolerability and Pharmacokinetics of Single Rising Oral Doses of BI 113823 Powder in Bottle (PiB) and Tablet in Healthy Male Volunteers
NCT02259972 ·Status: COMPLETED ·Phase: PHASE1
-
Safety, Tolerability, Pharmacokinetics of Single Rising Oral Doses of BI 1181181 in Healthy Male Volunteers, Including Investigation of the Effect of Food on the Bioavailability of BI 1181181
NCT02044406 ·Status: COMPLETED ·Phase: PHASE1
-
Safety, Pharmacokinetics, and Pharmacodynamics of BIRT 2584 XX in Healthy Male Volunteers
NCT02259894 ·Status: COMPLETED ·Phase: PHASE1
-
Safety, Pharmacodynamics, and Pharmacokinetics After Multiple Different Oral Doses of BIIB 722 CL Tablets in Healthy Volunteers
NCT02268604 ·Status: TERMINATED ·Phase: PHASE1
-
Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single Rising Oral Doses of BI 11634 Solution in Healthy Male Volunteers
NCT02214914 ·Status: COMPLETED ·Phase: PHASE1
-
A Safety, Tolerability, Pharmacokinetic, and Pharmacodynamic Study of BIIB091, a Bruton's Tyrosine Kinase (BTK) Inhibitor, in Healthy Adult Participants
NCT03943056 ·Status: COMPLETED ·Phase: PHASE1
-
Safety, Tolerance, and Pharmacokinetics of BILN 2061 ZW in Healthy Male Subjects, Combined With Preliminary Evaluation of Food Effect
NCT02268760 ·Status: COMPLETED ·Phase: PHASE1
-
Safety, Tolerability and Pharmacokinetics of Increasing Repeated Doses of BIIF 1149 BS in Healthy Male Volunteers
NCT02203487 ·Status: COMPLETED ·Phase: PHASE1
-
Safety Tolerability and Pharmacokinetic of BI 409306
NCT01343706 ·Status: COMPLETED ·Phase: PHASE1
-
A Safety, Tolerability and Preliminary Pharmacokinetics of BILR 355 BS Single-rising Dose Study in Healthy Male Volunteers
NCT02254538 ·Status: COMPLETED ·Phase: PHASE1
-
Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Multiple, Rising Oral Doses of BI 11634 Oral Solution in Healthy Male Volunteers
NCT02214940 ·Status: COMPLETED ·Phase: PHASE1
-
Safety, Pharmacokinetics and Pharmacodynamics After Single Rising Oral Doses of BIBR 1048 MS as Capsules in Healthy Subjects of Japanese and Caucasian Origin
NCT02170844 ·Status: COMPLETED ·Phase: PHASE1
-
Tolerability and Pharmacokinetics/-Dynamics of Single Rising Doses BIBT 986 BS in Healthy Male Subjects
NCT02254057 ·Status: COMPLETED ·Phase: PHASE1
-
Pharmacokinetics of BIBB 515 BS and Effect of Food After Oral Administration in Healthy Subjects
NCT02266498 ·Status: COMPLETED ·Phase: PHASE1
-
Safety, Tolerance, and Pharmacokinetics of Single Rising Oral Doses of BILB 1941 ZW Solution in Healthy Male Subjects, Followed With Bioavailability Comparison of BILB 1941 ZW Tablet and Solution Formulation Administered With or Without Food
NCT02256787 ·Status: COMPLETED ·Phase: PHASE1
-
Safety, Pharmacodynamics, and Pharmacokinetics of BIBT 1011 BS in Healthy Subjects
NCT02182037 ·Status: COMPLETED ·Phase: PHASE1
-
Pharmacodynamics, Safety and Pharmacokinetics After Oral Administration of BIBR 1048 MS in Healthy Volunteers
NCT02170116 ·Status: COMPLETED ·Phase: PHASE1
-
Investigation of Pharmacokinetics of BIBX 245 CL and Safety in Healthy Subjects
NCT02264197 ·Status: COMPLETED ·Phase: PHASE1
-
Safety, Pharmacokinetics, and Pharmacodynamics of BIRT 2584 XX Administered as Multiple Doses and Safety and Pharmacokinetics of BIRT 2584 XX Administered With and Without Food as Single Dose to Healthy Male Volunteers
NCT02256761 ·Status: COMPLETED ·Phase: PHASE1
-
Assessment of Safety, Pharmacokinetics and the Effect of BIBR 1048 MS on Coagulation Parameters in Healthy Volunteer Subjects
NCT02170740 ·Status: COMPLETED ·Phase: PHASE1
-
Study to Investigate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single Rising Doses of BI 187004 CL
NCT01587417 ·Status: COMPLETED ·Phase: PHASE1
-
Safety, Pharmacokinetics and Pharmacodynamics After Multiple Oral Doses of BIBR 1048 MS Capsule in Healthy Japanese Male Subjects
NCT02171000 ·Status: COMPLETED ·Phase: PHASE1