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

NCT00675064 | Completed Phase 1

• 1 other identifier: ISO105774
• Study Type: interventional
• Target: 41
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Malaria

Keywords

pharmacokinetics,; safety; single ascending dose,; Healthy volunteers,

Outcome Measures

Primary Outcomes (1)

• Safety and tolerability

  From Day 1 to follow-up visit

Secondary Outcomes (1)

• Pharmacokinetics

  Day 1 to Day 4

Study Arms (2)

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.

Drug: GSK369796

Matching placebo

ACTIVE COMPARATOR

After randomization subjects will receive matching placebo of GSK3697969.

Drug: Placebo

Interventions

GSK369796 DRUG

Anti-malarial

Anti-malarial experimental drug

Placebo DRUG

Placebo matching GSK369796

Matching placebo

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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:
• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• GlaxoSmithKline: lead
• Medicines for Malaria Venture: collaborator

Study Sites (1)

GSK Investigational Site

London, NW10 7NS, United Kingdom

Location

Related Links

• Results for study ISO105774 can be found on the GSK Clinical Study Register.

MeSH Terms

Conditions

Malaria

Interventions

N-tert-butylisoquine

Condition Hierarchy (Ancestors)

Protozoan Infections; Parasitic Diseases; Infections; Mosquito-Borne Diseases; Vector Borne Diseases

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 22, 2008
• First Posted: May 8, 2008
• Study Start: May 2, 2008
• Primary Completion: October 12, 2008
• Study Completion: October 12, 2008
• Last Updated: September 13, 2018

Record last verified: 2018-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: IPD is available via the Clinical Study Data Request site (click on the link provided below)
• Access Criteria: 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.

Locations

GB (1)