Safety and Pharmacokinetic Study of BIO 300 Capsules
NCT00504335 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 24
Last updated 2015-03-17
Summary
This trial is designed to evaluate the safety and pharmacokinetics of BIO 300 capsules when administered orally to healthy male and female volunteers. BIO 300 is expected to be safe for use starting at 500 mg.
Conditions
- Acute Radiation Syndrome
Interventions
- DRUG
-
BIO 300 Capsules
Sponsors & Collaborators
-
United States Department of Defense
collaborator FED -
Humanetics Corporation
lead INDUSTRY
Principal Investigators
-
John L Zenk, MD · Humanetics Corporation
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Max Age
- 64 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2007-06-30
- Primary Completion
- 2007-09-30
- Completion
- 2007-10-31
More Related Trials
-
Safety and Pharmacokinetics of Single Rising Oral Doses of BI 224436 ZW in Healthy Male Volunteers.
NCT02183662 ·Status: COMPLETED ·Phase: PHASE1
-
Pharmacokinetics and Pharmacodynamics of Multiple 5 mg Doses of BI 1356 p.o. Given Once Daily Compared to Multiple 2.5 mg Doses Given Twice Daily in Healthy Male and Female Volunteers
NCT02173652 ·Status: COMPLETED ·Phase: PHASE1
-
Investigation of the Metabolism and Pharmacokinetics of 10 mg [14C] BI 1356 Administered Orally Compared to 5 mg [14C] BI 1356 Administered Intravenously in Healthy Male Volunteers
NCT02183610 ·Status: COMPLETED ·Phase: PHASE1
-
Safety, Tolerability, and Pharmacokinetics of BI 201335 NA in Healthy Male Subjects
NCT02182297 ·Status: COMPLETED ·Phase: PHASE1
-
Metabolism and Pharmacokinetics of [14C]-BI 44370 BS Administered as an Oral Solution in Healthy Male Volunteers
NCT02215772 ·Status: COMPLETED ·Phase: PHASE1
-
Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single Rising Oral Doses and Multiple Rising Oral Doses of BI 1356 BS in Healthy Male Volunteers
NCT02183311 ·Status: COMPLETED ·Phase: PHASE1
-
Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single Rising Oral Doses of BI 1356 BS Administered to Healthy Male Subjects
NCT02173665 ·Status: COMPLETED ·Phase: PHASE1
-
Pharmacokinetics of Single and Multiple Oral Doses of BI 1356 in Healthy Chinese Volunteers
NCT02183532 ·Status: COMPLETED ·Phase: PHASE1
-
A Study in Healthy Men to Test How BI 764198 is Processed in the Body
NCT05863130 ·Status: COMPLETED ·Phase: PHASE1
-
Safety, Tolerability and Pharmacokinetics of Multiple Rising Doses of BI 113608 in Healthy Male Volunteers
NCT01681277 ·Status: COMPLETED ·Phase: PHASE1
-
Safety, Tolerance, and Pharmacokinetics of Single Oral Doses of BI 201335 NA and Bioavailability in Healthy Male Subjects
NCT02182323 ·Status: COMPLETED ·Phase: PHASE1
-
Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single Rising Doses of BI 1356 BS in Healthy Male Volunteers
NCT02183298 ·Status: COMPLETED ·Phase: PHASE1
-
Safety, Tolerability and Pharmacokinetics of Multiple Rising Doses of BI 201335 NA in Healthy Male Subjects
NCT02182362 ·Status: COMPLETED ·Phase: PHASE1
-
Relative Bioavailability of BI 201335 Capsule Versus Three Different Oral Solutions
NCT01764945 ·Status: COMPLETED ·Phase: PHASE1
-
Bioavailability of BI 1356 Administered With and Without Food to Healthy Male and Female Subjects
NCT02183493 ·Status: COMPLETED ·Phase: PHASE1
-
Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single Rising Oral Doses of BI 44847 Powder in Healthy Male Subjects
NCT02209844 ·Status: COMPLETED ·Phase: PHASE1
-
BI 10773 Administered as Oral Solution to Healthy Male Volunteers
NCT02172274 ·Status: COMPLETED ·Phase: PHASE1
-
Safety, Tolerability and Pharmacokinetics of BI 44370 TA Oral Drinking Solution in Healthy Male Volunteers
NCT02215018 ·Status: COMPLETED ·Phase: PHASE1
-
This Study Tests How Different Doses of BI 1291583 Are Taken up in the Body and How Well They Are Tolerated
NCT03414008 ·Status: TERMINATED ·Phase: PHASE1
-
A Study in Healthy Men to Test How BI 1358894 is Taken up and Handled by the Body
NCT04567316 ·Status: COMPLETED ·Phase: PHASE1
-
Safety, Tolerability and Pharmacokinetics of Multiple Rising Oral Doses of BI 1015550 Powder for Oral Solution
NCT01835899 ·Status: COMPLETED ·Phase: PHASE1
-
Metabolism and Pharmacokinetics of [14C]-BIBF 1120 in Healthy Male Volunteers
NCT02182154 ·Status: COMPLETED ·Phase: PHASE1
-
Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single Rising Oral Doses of BI 10773 in Healthy Male Subjects
NCT02172170 ·Status: COMPLETED ·Phase: PHASE1
-
Effects of BI 201335 NA on Cytochrome P450 and P-glycoprotein Activity Using a Probe Drug Cocktail in Healthy Volunteers
NCT02182336 ·Status: COMPLETED ·Phase: PHASE1
-
Relative Bioavailability of BI 1467335 Tablet and Oral Solution, and Food Effect on Tablet in Healthy Male Subjects
NCT02999191 ·Status: COMPLETED ·Phase: PHASE1