Last updated: 11/04/2018 11:16:09

Study to Test Safety, Tolerability and Blood Levels of GSK971086 after 1 Dose & 7 Days of Dosing in Healthy Adult Males

GSK study ID
SAR109935
Clinicaltrials.gov ID
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Completed
Completed
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

Trial overview

Official title: A Randomized, Double-Blind, Placebo Controlled, Dose Escalation Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of GSK971086 after a Single Dose and 7 Days of Repeat Dosing in Healthy Adult Male Volunteers
Trial description: This research study is the first administration of GSK971086 in humans. The purpose of this study is to assess the safety and tolerability of GSK971086, as well as, how much GSK971086 is in your blood after different doses
Primary purpose:
Treatment
Trial design:
Single Group Assignment
Masking:
Not applicable
Allocation:
Randomized
Primary outcomes:

Adverse events:

Timeframe: all visits

hematology, clinical chemistry, urinalysis:

Timeframe: Part A Days -2,2,3,14,28 & Part B Days -2,2,5,8,14,21,35

vital signs & 12-lead ECGs:

Timeframe: Part A Days -2-3,7,28 & Part B Days -2-9,14,35

Secondary outcomes:

GSK 971086 Plasma blood level:

Timeframe: art A Days 1,2,3,7,14,21,28 & Part B Days 1-9,14,21,28,35

PBone & muscle biomarkers:

Timeframe: Part A Days 1,2,7,14,21,28 & Part B Days 1,3,8,14,21,28,35

Interventions:
Drug: placebo
Drug: GSK971086
Enrollment:
126
Observational study model:
Not applicable
Primary completion date:
Not applicable
Time perspective:
Not applicable
Clinical publications:
Not applicable
Medical condition
Healthy Subjects
Product
GSK971086
Collaborators
Not applicable
Study date(s)
August 2007 to April 2008
Type
Interventional
Phase
1

Participation criteria

Sex
Male
Age
18 - 50 years
Accepts healthy volunteers
Yes
  • Males between 18 and 50 years of age (inclusive), at the time of signing the informed consent form.
  • Healthy, as determined by the Investigator, based on medical evaluations performed during the Screening Period including medical history, physical examination, clinical laboratory tests, and cardiac monitoring.
  • Subjects with a history of clinically significant endocrine, gastrointestinal, hepatic,cardiovascular, neurological, haematological, immunological, renal, respiratory, or genitourinary abnormalities or diseases.
  • Subjects with a history at any time in the past of coronary artery disease, congestive heart failure, angina, myocardial infarction, any cardiac surgery, valvular heart disease, clinically significant arrhythmia, dyspnea, pulmonary edema, stroke, or transient ischemic attack. ECG exclusion criteria as defined in the protocol.

Trial location(s)

Location
Status
Contact us
Contact us
Location
GSK Investigational Site
EVANSVILLE, Indiana, United States, 47714
Status
Study Complete

Study documents

No study documents available.

Results overview

Study Results yet to be posted

Recruitment status
Completed
Actual primary completion date
Not applicable
Actual study completion date
2008-28-04

Plain language summaries

Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.

Additional information about the trial

Additional information
Not applicable
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