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CompletedNCT00675064Updated Sep 13, 2018

Single-Blind, Placebo-Controlled, Randomized Study Testing Single Ascending Doses Of GSK369796 In Healthy Subjects

A Phase 1 interventional study of GSK369796 and Placebo in Malaria, sponsored by GlaxoSmithKline. Completed at 1 site in United Kingdom. Open to participants aged 18 Years to 40 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-09-13.

Sponsored by GlaxoSmithKline · Phase 1, Interventional, and Other

Phase
Phase 1
Study type
Interventional
Enrollment
41
Allocation
Randomized
Ages
18 Years to 40 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Malaria

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Keywords

  • pharmacokinetics,
  • safety
  • single ascending dose,
  • Healthy volunteers,
03

In context

Malaria

1,299 studies on the registry are indexed under Malaria; 86 are open to participants now.

This study's enrollment of 41 is below the median of 220 across 1,027 interventional studies indexed under Malaria.

Browse Malaria studies →

Lead sponsor

GlaxoSmithKline is the lead sponsor of 3,562 studies on the registry; 117 are open to participants now.

Of its 258 completed or terminated interventional studies of FDA-regulated products, 232 (90%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 40 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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:

    1. 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.
    2. 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

Exclusion criteria

Exclusion Criteria:

  • 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.
  • 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
05

Study design

Phase
Phase 1
Primary purpose
Other
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
41 participants (actual)

Study arms

  • Experimental
    Anti-malarial experimental drug

    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.

    Drug: GSK369796

  • Active comparator
    Matching placebo

    After randomization subjects will receive matching placebo of GSK3697969.

    Drug: Placebo

Interventions

  • DrugGSK369796

    Anti-malarial

  • DrugPlacebo

    Placebo matching GSK369796

06

What researchers measure

Primary outcomes

  1. Safety and tolerability

    Time frame: From Day 1 to follow-up visit

Secondary outcomes

  1. Pharmacokinetics

    Time frame: Day 1 to Day 4

07

Study locations

1 site
  • GSK Investigational Site
    London, NW10 7NS, United Kingdom
08

References and documents

Individual participant data

Plan to share: Yes — IPD for this study will be made available via the Clinical Study Data Request site.

Supporting information: Study protocol, Sap, Icf, Csr

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 13, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00675064
Lead sponsor
GlaxoSmithKline
Collaborators
Medicines for Malaria Venture
Responsible party
Sponsor
First posted
May 8, 2008
Start date
May 2, 2008
Primary completion
Oct 12, 2008
Completion
Oct 12, 2008
Last update
Sep 13, 2018

Study contacts

GSK Clinical Trials
study director · GlaxoSmithKline

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2018. You cannot join it, but the record below documents what was studied.

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