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

GlaxoSmithKline1 site in 1 country126 target enrollmentAugust 2007

ConditionsHealthy Subjects Androgen Deficiency

Drugsplacebo GSK971086

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Healthy Subjects
Sponsor: GlaxoSmithKline
Enrollment: 126
Locations: 1
Primary Endpoint: Adverse events:
Status: Completed
Last Updated: 14 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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

Registry

clinicaltrials.gov

Start Date

August 2007

End Date

April 2008

Last Updated

14 years ago

Study Type

Interventional

Study Design

Single Group

Sex

Male

Investigators

Sponsor

GlaxoSmithKline

Responsible Party

Sponsor

Eligibility Criteria

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.

Outcomes

Primary Outcomes

Adverse events:

Time Frame: all visits

hematology, clinical chemistry, urinalysis:

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

vital signs & 12-lead ECGs:

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

Secondary Outcomes

GSK 971086 Plasma blood level:(art A Days 1,2,3,7,14,21,28 & Part B Days 1-9,14,21,28,35)
PBone & muscle biomarkers:(Part A Days 1,2,7,14,21,28 & Part B Days 1,3,8,14,21,28,35)