A First Time in Human Study in Healthy Volunteers to Investigate a New Medicine to Treat Malaria

NCT00811356 | Terminated Phase 1

• 1 other identifier: 111319
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to determine if the study drug (antimalarial medication) is safe when given to healthy subjects as a single dose or as repeated doses, to understand the effect of food on single doses of study drug and to determine if the study drug has an effect on other approved medications such as rosiglitazone and rosuvastatin.

Conditions

Malaria

Keywords

Food Effect; Drug-Drug Interaction; Antimalarial; First Time In Human; Single Dose; Repeat Dose

Outcome Measures

Primary Outcomes (1)

• Evidence of safety as determined by assessing adverse events, vital signs, spirometry, ECGs, telemetry, renal biomarkers, safety labs, and physical examination

  Part A: 3-4 months; Part B: ~1 month

Secondary Outcomes (1)

• Plasma or blood concentrations of study drug

  Part A: 3-4 months; Part B: ~1 month

Study Arms (1)

Single Dose, Repeat Dose, Drug-Drug Interaction

EXPERIMENTAL

GSK932121 or placebo will be administered as a single dose with or without food in a dose escalation manner. Once the results from the single dose is obtained and reviewed, GSK932121 or placebo will be administered as a repeat dose. The results from each repeat dose level will be reviewed prior to determining the next repeat dose level. To better understand the effect of GSK932121 on rosiglitazone and rosuvastatin, a drug-drug interaction arm will also be investigated in this study. Rosiglitazone and rosuvastatin will be administered alone, then GSK932121 will be given as a repeat dose. Rosiglitazone and rosuvastatin will then be administered in combination with GSK932121.

Drug: GSK932121; Rosiglitazone; Rosuvastatin

Interventions

GSK932121; Rosiglitazone; Rosuvastatin DRUG

GSK932121 is the study drug that will be tested in all parts of this study as described above. Rosiglitazone and rosuvastatin will only be tested in the drug-drug interaction substudy.

Single Dose, Repeat Dose, Drug-Drug Interaction

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Male or female between 18 and 50 years of age, inclusive
• Females of non-childbearing potential (as pre-menopausal females with a documented tubal ligation or hysterectomy; or postmenopausal defined as 12 months of spontaneous amenorrhea
• Body weight \> 50 kg and BMI within the range 19 - 31 kg/m2 (inclusive)
• QTcB or QTcF \< 450 msec; or QTc \< 480 msec in subjects with Bundle Branch Block

You may not qualify if:

• Positive pre-study drug/alcohol screen
• Positive pre-study Hepatitis B surface antigen or positive Hepatitis C antibody result within 3 months of screening.
• A positive test for HIV antibody
• History of regular alcohol consumption within 6 months of the study
• Participation in a clinical trial with an investigational product within 30 days or 5 half-lives of the investigational product (whichever is longer) prior to start of the new study
• Exposure to more than four new drugs or within 12 months prior to the first dosing day
• Use of prescription or non-prescription drugs, including vitamins, herbal and dietary supplements (including St John's Wort) within 7 days or 5 half-lives (whichever is longer) prior to the first dose of study medication
• History of sensitivity to any of the study medications, or components thereof or a history of drug or other allergy that would be contraindicated
• Donation of blood or blood products in excess of 500 mL within a 56 day period.
• Pregnant females as determined by positive serum or urine hCG test at screening or prior to dosing.
• Lactating females.
• Unwillingness or inability to follow the procedures outlined in the protocol.
• History of sensitivity to heparin or history of heparin-induced thrombocytopenia if heparin is used to maintain the patency of an intravenous cannula.
• Asthma or a history of asthma
• Smoking or history or regular use of tobacco- or nicotine-containing products within 2 months prior to screening

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (1)

GSK Investigational Site

Melbourne, Victoria, 3004, Australia

Location

Related Links

• Results for study 111319 can be found on the GSK Clinical Study Register.
• Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.

MeSH Terms

Conditions

Malaria

Interventions

Rosiglitazone; Rosuvastatin Calcium

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Thiazolidinediones; Thiazoles; Sulfur Compounds; Organic Chemicals; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Sulfonamides; Amides; Fluorobenzenes; Hydrocarbons, Fluorinated; Hydrocarbons, Halogenated; Hydrocarbons; Sulfones; Pyrimidines

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Study Design

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

Study Record Dates

• First Submitted: December 18, 2008
• First Posted: December 19, 2008
• Study Start: December 11, 2008
• Primary Completion: March 30, 2009
• Study Completion: March 30, 2009
• Last Updated: August 3, 2017

Record last verified: 2017-08

Data Sharing

• IPD Sharing: Will share

Locations

AU (1)