Fimasartan (BR-A-657) Multiple Oral Dose in Healthy Subjects

Study Overview
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Brief Summary
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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.

Detailed Description
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BR-A-657 120, 360, or placebo were administered once daily for 7days to 16 healthy male subjects. Pharmacokinetic and Pharmacodynamic(PK/PD) parameters were monitored at pre-specified times from each subjects. PK parameters: Area Under the Curve(AUC), Cmax, half-life, etc. PD parameters: Aldosterone, Plasma renin activity, Angiotensin I, Angiotensin II Adverse events are reported.

Official Title
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BR-A-657, A Phase 1, Double-blind, Placebo-controlled, Ascending Multiple Oral Dose Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Study in Healthy Male Subjects

Conditions
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Essential Hypertension

Intervention / Treatment
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* Drug: BR-A-657


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: male of 18-55 years old BMI 19-29kg/m2 subjects in good health subjects with written informed consent Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm A<br>BR-A-657 120mg or placebo | Drug: BR-A-657<br>* 120, 360mg or placebo 7days<br>* Other names: Fimasartan;|
| Experimental: Arm B<br>BR-A-657 360mg or placebo | Drug: BR-A-657<br>* 120, 360mg or placebo 7days<br>* Other names: Fimasartan;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| No of subjects with Adverse events(AE) from each observations | AE reporting: Day 1: Predose, 3 & 12h, Days 2 7: Predose, Days 8,9: Once daily, 5 7days post final dose 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 ECG: Days 1 & 7: Predose, 2, 4, 8 & 24h, Day 4: Predose, 5 7days post final dose Laboratory examination: Days 1 & 4: Predose, Day 7: Predose & 24h, 5 7days post final dose Physical examination: predose, 5 7days post final dose Body weight: predose, Days 4 & 8 | up to 5 7days post final(7th) dose | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | RA1=Accumulation ratio based on AUCinf RA2=Accumulation ratio based on Cmax | predose,0.5,1,1.5,2,3,4,6,8,12,16,24,(48)h on day 1 and day 7 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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BR-A-657, Fimasartan, multiple-dose, pharmacokinetic, pharmacodynamic, safety