Fimasartan (BR-A-657) Single 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 single oral dose of BR-A-657 in healthy male subjects.

Detailed Description
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BR-A-657 20, 50, 120, 240, 360, 480mg or placebo were administered once to 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 Single Oral Dose Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Study in Healthy Male Subjects Incorporating a Comparison of Fed/Fasted Pharmacokinetics

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 Body Mass Index(BMI) 19-29kg/m2 subjects in good health subjects with written informed consent Exclusion Criteria: subjects with multiple drug allergy or allergy to Angiotensin Receptor Blocker(ARB) subjects with medication that affect drug absorption or elimination within 30days. subjects with orthostatic hypotension of >20mmHg decrease of Systolic Blood Pressure(SBP) subjects with history of neurologic, liver, renal, gastrointestinal, cardiovascular, 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 |
| --- | --- |
| Other: Arm A<br>BR-A-657 20mg or placebo | Drug: BR-A-657<br>* 20, 60, 120, 240, 360, 480mg or placebo tablet<br>* Other names: 20, 60, 120, 240, 360, 480mg;|
| Other: Arm B<br>BR-A-657 60mg or placebo | Drug: BR-A-657<br>* 20, 60, 120, 240, 360, 480mg or placebo tablet<br>* Other names: 20, 60, 120, 240, 360, 480mg;|
| Other: Arm C<br>BR-A-657 120mg or placebo | Drug: BR-A-657<br>* 20, 60, 120, 240, 360, 480mg or placebo tablet<br>* Other names: 20, 60, 120, 240, 360, 480mg;|
| Other: Arm D<br>BR-A-657 240mg or placebo | Drug: BR-A-657<br>* 20, 60, 120, 240, 360, 480mg or placebo tablet<br>* Other names: 20, 60, 120, 240, 360, 480mg;|
| Other: Arm E<br>BR-A-657 480mg or placebo | Drug: BR-A-657<br>* 20, 60, 120, 240, 360, 480mg or placebo tablet<br>* Other names: 20, 60, 120, 240, 360, 480mg;|

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: Pre dose, 3, 12, 24h, (48 h: Groups C, D, E) post dose Vital signs: Pre dose*, 0.5, 1*, 2, 4*, 6, 8*, 12 and 24* h post dose (*:both supine and standing) ECG: Pre dose, 2, 4, 8 and 24 h post dose Clinical laboratory examination: Pre dose and 24 h post dose Physical examination: predose, 5 7days post dose Body weight: predose, 5 7days post dose | up to 5 7days post-dose | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Area under the plasma concentration time curve (AUC) |  | 0.5,1,1.5,2,3,4,6,8,12,16,24,(48: Groups C, D, E)h | 
| Maximum observed plasma concentration (Cmax) |  | 0.5,1,1.5,2,3,4,6,8,12,16,24,(48: Groups C, D, E)h | 
| Time of the maximum observed plasma concentration (Tmax) |  | 0.5,1,1.5,2,3,4,6,8,12,16,24,(48: Groups C, D, E)h | 
| Apparent total plasma clearance (CL/F) |  | 0.5,1,1.5,2,3,4,6,8,12,16,24,(48: Groups C, D, E)h | 
| Apparent plasma terminal elimination half life (t½) |  | 0.5,1,1.5,2,3,4,6,8,12,16,24,(48: Groups C, D, E)h | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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single-dose, pharmacokinetic, pharmacodynamic, safety