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

This study has been completed.
Sponsor:
Collaborator:
Covance Clinical Research Unit Ltd.
Information provided by:
Boryung Pharmaceutical Co., Ltd
ClinicalTrials.gov Identifier:
NCT01289899
First received: December 14, 2010
Last updated: February 3, 2011
Last verified: February 2011
  Purpose

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.


Condition Intervention Phase
Essential Hypertension
Drug: BR-A-657
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Official Title: BR-A-657, A Phase 1, Double-blind, Placebo-controlled, Ascending Multiple Oral Dose Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Study in Healthy Male Subjects

Resource links provided by NLM:


Further study details as provided by Boryung Pharmaceutical Co., Ltd:

Primary Outcome Measures:
  • No of subjects with Adverse events(AE) from each observations [ Time Frame: up to 5~7days post final(7th) dose ] [ Designated as safety issue: Yes ]
    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


Secondary Outcome Measures:
  • Area under the plasma concentration time curve (AUC) [ Time Frame: predose,0.5,1,1.5,2,3,4,6,8,12,16,24,(48)h on day 1 and day 7 ] [ Designated as safety issue: Yes ]
  • Maximum observed plasma concentration (Cmax). [ Time Frame: predose,0.5,1,1.5,2,3,4,6,8,12,16,24,(48)h on day 1 and day 7 ] [ Designated as safety issue: Yes ]
  • parent plasma terminal elimination half life (t½) [ Time Frame: predose,0.5,1,1.5,2,3,4,6,8,12,16,24,(48)h on day 1 and day 7 ] [ Designated as safety issue: Yes ]
  • Apparent total plasma clearance (CL/F) [ Time Frame: predose,0.5,1,1.5,2,3,4,6,8,12,16,24,(48)h on day 1 and day 7 ] [ Designated as safety issue: Yes ]
  • Accumulation ratio (RA) [ Time Frame: predose,0.5,1,1.5,2,3,4,6,8,12,16,24,(48)h on day 1 and day 7 ] [ Designated as safety issue: Yes ]

    RA1=Accumulation ratio based on AUCinf

    RA2=Accumulation ratio based on Cmax



Enrollment: 16
Study Start Date: January 2004
Study Completion Date: February 2004
Primary Completion Date: February 2004 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm A
BR-A-657 120mg or placebo
Drug: BR-A-657
120, 360mg or placebo 7days
Other Name: Fimasartan
Experimental: Arm B
BR-A-657 360mg or placebo
Drug: BR-A-657
120, 360mg or placebo 7days
Other Name: Fimasartan

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01289899

Sponsors and Collaborators
Boryung Pharmaceutical Co., Ltd
Covance Clinical Research Unit Ltd.
Investigators
Principal Investigator: E Engmann, MB ChB Covance Clinical Research Unit
  More Information

No publications provided

Responsible Party: Paik, Assistant manager, Boryung Pharm. Co., Ltd
ClinicalTrials.gov Identifier: NCT01289899     History of Changes
Other Study ID Numbers: 2290/9
Study First Received: December 14, 2010
Last Updated: February 3, 2011
Health Authority: United Kingdom: Research Ethics Committee

Keywords provided by Boryung Pharmaceutical Co., Ltd:
BR-A-657
Fimasartan
multiple-dose
pharmacokinetic
pharmacodynamic
safety

Additional relevant MeSH terms:
Hypertension
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on July 28, 2014