MalariaPhase 1NCT00675064
Single-Blind, Placebo-Controlled, Randomized Study Testing Single Ascending Doses Of GSK369796 In Healthy Subjects
A Phase 1 study testing GSK369796 in people with Malaria, run by GlaxoSmithKline at 1 site in United Kingdom.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Malaria
- What is being tested?
- GSK369796
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 41 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 2 May 2008to 12 Oct 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 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
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- 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:
- non-childbearing potential (i.e. physiologically incapable of becoming pregnant). This includes pre-menopausal females with documented (medical report verification) hysterectomy or double oophrectomy or postmenopausal defined as 12 months of spontaneous amenorrhea or 6 months of spontaneous amenorrhea with serum FSH levels > 40 mIU/mL or 6 weeks postsurgical bilateral oophorectomy with or without hysterectomy, or documented hysterectomy - tubal ligation is not sufficient.
- childbearing potential and agrees to commit to two of the protocol-approved methods of contraception, when used consistently and in accordance with both the product label and the instructions of a physician (and as listed in protocol).
- 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
Who cannot join
- Any clinically relevant abnormality identified on the screening history and physical exam, screening 12-lead surface electrocardiogram (ECG), and screening 24-holter cardiac monitoring.
- Any evidence of cardiac disease or other clinically relevant abnormality identified on the screening echocardiography.
- Any clinically relevant abnormality on the clinical safety laboratory tests at screening.
- Positive for Human Immunodeficiency Virus (HIV) antibody, hepatitis B virus surface antigen, or hepatitis C virus antibody at screening.
- Significant cardiac history including but not limited to history of myocardial infarction, angina, heart failure, cardiomyopathy, arrhythmia, myocarditis, hypertrophy (atrial or ventricular), or cor pulmonale.
- Significant central nervous system (e.g., seizures), pulmonary, metabolic, renal, hepatic or gastrointestinal conditions or history of such conditions that, in the opinion of the investigator and/or GSK medical monitor, places the subject at an unacceptable risk as a participant in this trial or may interfere with the absorption, distribution, metabolism or excretion of drugs.
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- History of sensitivity to any of the study medications or components thereof.
- History of sensitivity to 4-aminoquinolines (e.g., chloroquine, amodiaquine, or piperaquine).
- History of sensitivity to heparin or heparin-induced thrombocytopenia, if the clinical research unit will use heparin to maintain intravenous cannula patency.
- Use of prescription or non-prescription drugs, vitamins, herbal and dietary supplements within 14 days or 5 half-lives (whichever is longer) prior to study medication administration, or use of St. John's Wort within 28 days prior to the study medication administration Unless in the opinion of the investigator and sponsor the medication will not interfere with study procedures or compromise safety. By exception, the volunteer may take paracetamol (</ 2 grams/day) up to 48 hours prior to the study medication administration.
- Consumption of grapefruit, grapefruit juice, orange juice or Seville oranges, red wine within 7 days prior to administration of study medication.
- Participation in a clinical study of an investigational or non-investigational drug within 3 months or 5 half-lives (whichever is longer) preceding the study medication administration.
- Exposure to more than four new chemical entities within 12 months prior to dosing.
- History of drug abuse within 6 months of the study.
- A positive urine test for drugs of abuse or alcohol (or alcohol breath test) at screening or predose.
- History of smoking or use of nicotine containing products within 3 months of screening, or a positive urine cotinine indicative of smoking at screening.
- History of regular alcohol consumption exceeding 14 units/week or 2 units/day for women, or 21 units/week or 3 units/day for men, within 6 months of screening. One unit is equivalent to a half-pint of beer or 1 measure of spirits or 1 glass of wine.
- An unwillingness of male subjects to abstain from sexual intercourse with pregnant or lactating women, or an unwillingness of male subjects to use a condom/spermicide, in addition to having their female partner use another form of contraception such as an IUD, diaphragm with spermicide, oral contraceptives, injectable progesterone, subdermal implants or a tubal ligation, if engaging in sexual intercourse with a female partner who could become pregnant. This criterion must be followed from the time of study medication administration and until 84 days later.
- Donation of blood in excess of 500 mL within 90 days prior to dosing.
- An unwillingness to comply with lifestyle and/or dietary restrictions
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Single-blind, Placebo-controlled, Randomized Study Testing Single Ascending Doses of GSK369796 in Healthy Subjects
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.
- Conditions
- Malaria
- Being tested
- GSK369796, Placebo
- Keywords
- pharmacokinetics,, safety, single ascending dose,, Healthy volunteers,
- Medical subject headings
- Malaria
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GSK369796Drug
Anti-malarial
PlaceboDrug
Placebo matching GSK369796
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: GSK369796 |
| Matching placebo | Active comparator | After randomization subjects will receive matching placebo of GSK3697969. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and tolerability
Measured: From Day 1 to follow-up visit
Secondary outcomes (1)
Pharmacokinetics
Measured: Day 1 to Day 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2008 (estimated)
- Study start2 May 2008
- Primary completion12 Oct 2008
- Study completion12 Oct 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MalariaStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Medicines for Malaria Venture
- Responsible party
- Sponsor
- Investigators
- GSK Clinical Trials, Study director, GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00675064
- Sponsor's protocol ID
- ISO105774
- Status last verified
- Sep 2018
- First submitted
- 22 Apr 2008
- Last updated
- 13 Sep 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes: IPD for this study will be made available via the Clinical Study Data Request site.
Study at a glance
From the registry record, last updated by the sponsor on 13 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Single-blind, Placebo-controlled, Randomized Study Testing Single Ascending Doses of GSK369796 in Healthy Subjects
- ClinicalTrials.gov ID
- NCT00675064
- Acronym / sponsor ID
- ISO105774
- Conditions
- Malaria
- Keywords
- pharmacokinetics,, safety, single ascending dose,, Healthy volunteers,
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Collaborators
- Medicines for Malaria Venture
- Study start
- 2 May 2008 (actual)
- Primary completion
- 12 Oct 2008 (actual)
- Study completion
- 12 Oct 2008 (actual)
- First posted
- 8 May 2008 (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 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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Anti-malarial experimental drug | Experimental | Drug: GSK369796After 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 | Drug: PlaceboAfter randomization subjects will receive matching placebo of GSK3697969. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (15 listed)
- 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.
Key exclusion criteria (20 listed)
- Any clinically relevant abnormality identified on the screening history and physical exam, screening 12-lead surface electrocardiogram (ECG), and screening 24-holter cardiac monitoring.
- Any evidence of cardiac disease or other clinically relevant abnormality identified on the screening echocardiography.
- Any clinically relevant abnormality on the clinical safety laboratory tests at screening.
- Positive for Human Immunodeficiency Virus (HIV) antibody, hepatitis B virus surface antigen, or hepatitis C virus antibody at screening.
- Significant cardiac history including but not limited to history of myocardial infarction, angina, heart failure, cardiomyopathy, arrhythmia, myocarditis, hypertrophy (atrial or ventricular), or cor pulmonale.
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 |
|---|---|---|
| GSK369796Anti-malarial | Drug | Anti-malarial experimental drug |
| PlaceboPlacebo matching GSK369796 | Drug | Matching placebo |
Primary outcome
Safety and tolerability
Time frame: From Day 1 to follow-up visit
1 secondary outcome
Pharmacokinetics
Time frame: Day 1 to Day 4
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 13 Sep 2018.
- Results for study ISO105774 can be found on the GSK Clinical Study Register.Link provided by the sponsor.
- Individual participant dataSharing planned: Yes. IPD for this study will be made available via the Clinical Study Data Request site.
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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 GSK369796 in people with Malaria, run by GlaxoSmithKline at 1 site in United Kingdom.
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 15 inclusion and 20 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 13 Sep 2018. 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 Kingdom. 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?
Safety and tolerability (time frame: From Day 1 to follow-up visit). 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 13 Sep 2018.