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| Name | Class |
|---|---|
| Medicines for Malaria Venture | OTHER |
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This study will examine safety of single doses of GSK369796 in healthy subjects, along with some test to examine how quickly GSK369796 gets in your blood, and how long it takes your body to get rid of it.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Anti-malarial experimental drug | Experimental | After randomization subjects will receive either 5, 25, 100, 250, 500, 1000, 2000 and 3000 mg of GSK3697969 orally . GSK3697969 will be available as 5, 25 and 250 mg capsules. |
|
| Matching placebo | Active Comparator | After randomization subjects will receive matching placebo of GSK3697969. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GSK369796 | Drug | Anti-malarial |
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Safety and tolerability | From Day 1 to follow-up visit |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics | Day 1 to Day 4 |
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Inclusion Criteria:
Healthy adults between the ages of 18 to 40, inclusive.
Female subjects must be of non-childbearing potential including pre-menopausal females with documented (medical report verification) hysterectomy or bilateral oophrectomy or postmenopausal defined as 6 months of spontaneous amenorrhea with serum FSH levels > 40 mIU/ml.
Body weight > 50 kg and body mass index (BMI) between 19 and 30 kg/m2 where:
A screening electrocardiogram (12-lead ECG) with QTc <450 msec.
Troponin I £0.04 ng/mL at screening with Beckman Access2® AccuTnI™ Troponin I Assay.
The subject is able to understand and comply with protocol requirements, instructions and restrictions.
Signed and dated written informed consent prior to admission to the study
Healthy adult males and females between 18 and 60 years of age, inclusive. Whether a subject is "healthy" will be determined by a responsible physician, based on a medical evaluation including history, physical examination, laboratory tests, cardiac monitoring.
To be eligible, female subjects must have a negative pregnancy test (i.e. serum bhCG test) and be of:
Male subjects must agree to abstain from or use a condom during sexual intercourse with pregnant or lactating females; or use a condom/spermicide, in addition to having their female partner use another form of contraception, such as an IUD, diaphragm with spermicide, oral contraceptive, inject able progesterone, or sub dermal implant if engaging in sexual intercourse with a female partner who could become pregnant. This criterion must be followed from the time of the first dose of study medication until completion of follow up procedures.
Body weight ³ 50 kg (110 pounds) for men and ³ 45 kg (99 pounds) for women and body mass index (BMI) between 19 and 31.
Aspartate aminotransferase (AST), alanine aminotransferase (ALT) and bilirubin within reference range at screening.
Signed and dated written informed consent prior to admission to the study. The subject is able to understand and comply with protocol requirements, instructions and protocol-stated restrictions
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | GlaxoSmithKline | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GSK Investigational Site | London | NW10 7NS | United Kingdom |
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| Label | URL |
|---|---|
| Results for study ISO105774 can be found on the GSK Clinical Study Register. | View source |
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IPD for this study will be made available via the Clinical Study Data Request site.
IPD is available via the Clinical Study Data Request site (click on the link provided below)
Access is provided after a research proposal is submitted and has received approval from the Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension can be granted, when justified, for up to another 12 months.
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| ID | Term |
|---|---|
| D008288 | Malaria |
| ID | Term |
|---|---|
| D011528 | Protozoan Infections |
| D010272 | Parasitic Diseases |
| D007239 | Infections |
| D000096724 | Mosquito-Borne Diseases |
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| ID | Term |
|---|---|
| C540176 | N-tert-butylisoquine |
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| Drug |
Placebo matching GSK369796 |
|
| D000079426 |
| Vector Borne Diseases |