Healthy SubjectsPhase 1NCT00540553
Study to Test Safety, Tolerability and Blood Levels of GSK971086 After 1 Dose & 7 Days of Dosing in Healthy Adult Males
A Phase 1 study testing GSK971086 in people with Healthy Subjects and Androgen Deficiency, run by GlaxoSmithKline at 1 site in United States.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 to 50 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy Subjects, Androgen Deficiency
- What is being tested?
- GSK971086
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 126 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2007to Apr 2008
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 17Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
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
- Conditions
- Healthy Subjects, Androgen Deficiency
- Being tested
- placebo, GSK971086
- Keywords
- SARM,, FTIH,, pharmacokinetics
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
placeboDrug
GSK971086Drug
Also called placebo
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse events:
Measured: all visits
hematology, clinical chemistry, urinalysis:
Measured: Part A Days -2,2,3,14,28 & Part B Days -2,2,5,8,14,21,35
vital signs & 12-lead ECGs:
Measured: Part A Days -2-3,7,28 & Part B Days -2-9,14,35
Secondary outcomes (2)
GSK 971086 Plasma blood level:
Measured: art A Days 1,2,3,7,14,21,28 & Part B Days 1-9,14,21,28,35
PBone & muscle biomarkers:
Measured: Part A Days 1,2,7,14,21,28 & Part B Days 1,3,8,14,21,28,35
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2007 (estimated)
- Study startAug 2007
- Primary completionApr 2008
- Study completionApr 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy SubjectsStudies of the same condition, open and under way.
- More trials run by GlaxoSmithKlineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
- Enrolment
- 126 participants (actual)
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- GSK Clinical Trials, Study director, GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00540553
- Sponsor's protocol ID
- SAR109935
- Status last verified
- Feb 2011
- First submitted
- 4 Oct 2007
- Last updated
- 19 Mar 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00540553
- Acronym / sponsor ID
- SAR109935
- Conditions
- Healthy Subjects, Androgen Deficiency
- Keywords
- SARM,, FTIH,, pharmacokinetics
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 126 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- Aug 2007
- Primary completion
- Apr 2008 (actual)
- Study completion
- Apr 2008 (actual)
- First posted
- 8 Oct 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (17 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| placebo | Drug | – |
| GSK971086Also: placebo | Drug | – |
Primary outcome
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
2 secondary outcomes
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
PBone & muscle biomarkers:
Time frame: Part A Days 1,2,7,14,21,28 & Part B Days 1,3,8,14,21,28,35
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
GSK Clinical Trials study director
GlaxoSmithKline
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing GSK971086 in people with Healthy Subjects and Androgen Deficiency, run by GlaxoSmithKline at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Mar 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adverse events: (time frame: all visits). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Mar 2012.