Androgen Deficiency, Healthy Subjects
Conditions
Keywords
SARM,, FTIH,, pharmacokinetics
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
Interventions
DRUGplacebo
DRUGGSK971086
Sponsors
GlaxoSmithKline
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
DOUBLE
Eligibility
Sex/Gender
MALE
Age
18 Years to 50 Years
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Adverse events: | all visits |
| hematology, clinical chemistry, urinalysis: | Part A Days -2,2,3,14,28 & Part B Days -2,2,5,8,14,21,35 |
| vital signs & 12-lead ECGs: | Part A Days -2-3,7,28 & Part B Days -2-9,14,35 |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
Countries
United States
Outcome results
None listed