NCT01289886

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 single oral dose of BR-A-657 in healthy male subjects.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Sep 2003

Shorter than P25 for phase_1

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2003

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2003

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2003

Completed
7 years until next milestone

First Submitted

Initial submission to the registry

December 13, 2010

Completed
2 months until next milestone

First Posted

Study publicly available on registry

February 4, 2011

Completed
Last Updated

February 4, 2011

Status Verified

January 1, 2011

Enrollment Period

2 months

First QC Date

December 13, 2010

Last Update Submit

February 3, 2011

Conditions

Essential Hypertension

Keywords

single-dosepharmacokineticpharmacodynamicsafety

Outcome Measures

Primary Outcomes (1)

  • No of subjects with Adverse events(AE) from each observations

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

    up to 5~7days post-dose

Secondary Outcomes (5)

  • 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

Study Arms (5)

Arm A

OTHER

BR-A-657 20mg or placebo

Drug: BR-A-657

Arm B

OTHER

BR-A-657 60mg or placebo

Drug: BR-A-657

Arm C

OTHER

BR-A-657 120mg or placebo

Drug: BR-A-657

Arm D

OTHER

BR-A-657 240mg or placebo

Drug: BR-A-657

Arm E

OTHER

BR-A-657 480mg or placebo

Drug: BR-A-657

Interventions

BR-A-657DRUG

20, 60, 120, 240, 360, 480mg or placebo tablet

Also known as: Fimasartan, 20, 60, 120, 240, 360, 480mg
Arm AArm BArm CArm DArm E

Eligibility Criteria

Age18 Years - 55 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • male of 18-55 years old
  • Body Mass Index(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 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Essential Hypertension

Interventions

fimasartan

Condition Hierarchy (Ancestors)

HypertensionVascular DiseasesCardiovascular Diseases

Study Officials

  • E Engmann, MB ChB

    Covance Clinical Research Unit

    PRINCIPAL INVESTIGATOR

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 13, 2010

First Posted

February 4, 2011

Study Start

September 1, 2003

Primary Completion

November 1, 2003

Study Completion

December 1, 2003

Last Updated

February 4, 2011

Record last verified: 2011-01