Fimasartan (BR-A-657) Multiple Oral Dose in Healthy Subjects
BR-A-657, A Phase 1, Double-blind, Placebo-controlled, Ascending Multiple Oral Dose Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Study in Healthy Male Subjects
1 other identifier
interventional
16
0 countries
N/A
Brief Summary
The objective of this study is to determine the safety and tolerability and to determine the Pharmacokinetic and Pharmacodynamic(PK/PD) of ascending multiple oral dose of BR-A-657 in healthy male subjects.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1
Started Jan 2004
Shorter than P25 for phase_1
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2004
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2004
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2004
CompletedFirst Submitted
Initial submission to the registry
December 14, 2010
CompletedFirst Posted
Study publicly available on registry
February 4, 2011
CompletedFebruary 4, 2011
February 1, 2011
1 month
December 14, 2010
February 3, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
No of subjects with Adverse events(AE) from each observations
1. AE reporting: Day 1: Predose, 3 \& 12h, Days 2\~7: Predose, Days 8,9: Once daily, 5\~7days post final dose 2. Vital signs: Day 1: Predose, 0.5,1,2,4,8,12,24h,Days 3\~6: Predose Day 7: Predose, 0.5,1,2,4,8,12,24,48h, 5\~7days post final dose 3. ECG: Days 1 \& 7: Predose, 2, 4, 8 \& 24h, Day 4: Predose, 5\~7days post final dose 4. Laboratory examination: Days 1 \& 4: Predose, Day 7: Predose \& 24h, 5\~7days post final dose 5. Physical examination: predose, 5\~7days post final dose 6. Body weight: predose, Days 4 \& 8
up to 5~7days post final(7th) dose
Secondary Outcomes (5)
Area under the plasma concentration time curve (AUC)
predose,0.5,1,1.5,2,3,4,6,8,12,16,24,(48)h on day 1 and day 7
Maximum observed plasma concentration (Cmax).
predose,0.5,1,1.5,2,3,4,6,8,12,16,24,(48)h on day 1 and day 7
parent plasma terminal elimination half life (t½)
predose,0.5,1,1.5,2,3,4,6,8,12,16,24,(48)h on day 1 and day 7
Apparent total plasma clearance (CL/F)
predose,0.5,1,1.5,2,3,4,6,8,12,16,24,(48)h on day 1 and day 7
Accumulation ratio (RA)
predose,0.5,1,1.5,2,3,4,6,8,12,16,24,(48)h on day 1 and day 7
Study Arms (2)
Arm A
EXPERIMENTALBR-A-657 120mg or placebo
Arm B
EXPERIMENTALBR-A-657 360mg or placebo
Interventions
Eligibility Criteria
You may qualify if:
- male of 18-55 years old
- BMI 19-29kg/m2
- subjects in good health
- subjects with written informed consent
You may not qualify if:
- subjects with multiple drug allergy or allergy to ARB
- subjects with medication that affect drug absorption or elimination within 30days.
- subjects with orthostatic hypotension of \>20mmHg decrease of sbp
- subjects with history of neurologic, liver, renal, GI, CV, psychological or other major disorder
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Boryung Pharmaceutical Co., Ltdlead
- Covancecollaborator
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
E Engmann, MB ChB
Covance Clinical Research Unit
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
December 14, 2010
First Posted
February 4, 2011
Study Start
January 1, 2004
Primary Completion
February 1, 2004
Study Completion
February 1, 2004
Last Updated
February 4, 2011
Record last verified: 2011-02