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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00540553
Recruitment Status : Completed
First Posted : October 8, 2007
Last Update Posted : March 19, 2012
Information provided by (Responsible Party):

Brief Summary:
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

Condition or disease Intervention/treatment Phase
Healthy Subjects Androgen Deficiency Drug: placebo Drug: GSK971086 Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 126 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double
Primary Purpose: Treatment
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
Study Start Date : August 2007
Actual Primary Completion Date : April 2008
Actual Study Completion Date : April 2008

Intervention Details:
    Drug: placebo Drug: GSK971086
    Other Name: placebo

Primary Outcome Measures :
  1. Adverse events: [ Time Frame: all visits ]
  2. hematology, clinical chemistry, urinalysis: [ Time Frame: Part A Days -2,2,3,14,28 & Part B Days -2,2,5,8,14,21,35 ]
  3. vital signs & 12-lead ECGs: [ Time Frame: Part A Days -2-3,7,28 & Part B Days -2-9,14,35 ]

Secondary Outcome Measures :
  1. GSK 971086 Plasma blood level: [ Time Frame: art A Days 1,2,3,7,14,21,28 & Part B Days 1-9,14,21,28,35 ]
  2. PBone & muscle biomarkers: [ Time Frame: Part A Days 1,2,7,14,21,28 & Part B Days 1,3,8,14,21,28,35 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • 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 must agree to use an acceptable method of contraception as described in the protocol. These criteria must be followed from the time of the first dose of study drug until completion of the Final Safety and PK Visit in the Follow-up Period.
  • Body weight and Body Mass Index (BMI) within the ranges defined in the protocol.
  • Subject is able to understand and comply with protocol requirements, instructions, and protocol-stated restrictions, including those listed in the informed consent form.
  • Subject has given informed consent to participate in the study as indicated by providing a signed and dated written informed consent form prior to any study procedures.

Exclusion Criteria:

  • 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.
  • Subjects with a history of malignancy that is not in complete remission for at least 5 years, 1 year for non-melatonomatous skin carcinoma.
  • Subjects with values outside the specified ranges in the protocol for the following Key Clinical Laboratory Tests must be excluded from the study: liver function tests, renal function, electrolytes, metabolic, muscle and haematology.
  • Prostate Specific Antigen (PSA) >3.0ng/mL at Screening or subjects with a family history of early onset prostate cancer or multiple members with prostate cancer.
  • History of serious psychological disorders such as schizophrenia, uncontrolled bipolar disorder, and suicidal behaviour.
  • History of drug or alcohol abuse within 5 years prior to the Screening Period.
  • Positive test for illicit drugs or alcohol during Screening assessments. A minimum list of illicit drugs that will be screened for are listed in the protocol.
  • History of regular alcohol consumption averaging >14 drinks/week within 12 months prior to the Screening Period.
  • A positive test for Human Immunodeficiency Virus (HIV), Hepatitis B surface antigen, or Hepatitis C antibody upon screening, or at any time prior to the Screening Period.
  • Use of prescription or non-prescription drugs, including vitamins, herbal and dietary supplements (including St John's Wort) within 14 days or 5 half-lives (whichever is longer) prior to the first dose of study drug, however, the use of acetaminophen, ibuprofen, and naproxen will be allowed, as described in the protocol.
  • The subject has participated in a clinical trial and has received a drug or a new chemical entity within 30 days or 5 half-lives, or twice the duration of the biological effect of any drug (whichever is longer) prior to the first dose of current study drug.
  • History of drug or other allergy that, in the opinion of the Investigator, contraindicates their participation.
  • Where participation in study would result in donation of blood in excess of 500mL within a 56 day period.
  • History of sensitivity to heparin or heparin-induced thrombocytopenia.
  • Consumption of red wine, Seville oranges, grapefruit or grapefruit juice from 7 days prior to the first dose of study drug until check-out from the clinic on the last day of the Treatment Period.
  • Unwillingness to adhere to the study Lifestyle Guidelines as described in the protocol.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00540553

United States, Indiana
GSK Investigational Site
Evansville, Indiana, United States, 47714
Sponsors and Collaborators
Study Director: GSK Clinical Trials GlaxoSmithKline

Responsible Party: GlaxoSmithKline Identifier: NCT00540553     History of Changes
Other Study ID Numbers: SAR109935
First Posted: October 8, 2007    Key Record Dates
Last Update Posted: March 19, 2012
Last Verified: February 2011

Keywords provided by GlaxoSmithKline: