Trial Review

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT00811356




Registration number
NCT00811356
Ethics application status
Date submitted
18/12/2008
Date registered
19/12/2008
Date last updated
3/08/2017

Titles & IDs
Public title
A First Time in Human Study in Healthy Volunteers to Investigate a New Medicine to Treat Malaria
Scientific title
A Single-Blind, Placebo-Controlled, Randomized First Time in Human Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Single and Repeat Dose Escalation of GSK932121 in Healthy Adult Subjects
Secondary ID [1] 0 0
111319
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Malaria 0 0
Condition category
Condition code
Infection 0 0 0 0
Other infectious diseases
Infection 0 0 0 0
Studies of infection and infectious agents

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - GSK932121; Rosiglitazone; Rosuvastatin

Experimental: Single Dose, Repeat Dose, Drug-Drug Interaction - 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.


Treatment: Drugs: GSK932121; Rosiglitazone; Rosuvastatin
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.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Evidence of safety as determined by assessing adverse events, vital signs, spirometry, ECGs, telemetry, renal biomarkers, safety labs, and physical examination
Timepoint [1] 0 0
Part A: 3-4 months; Part B: ~1 month
Secondary outcome [1] 0 0
Plasma or blood concentrations of study drug
Timepoint [1] 0 0
Part A: 3-4 months; Part B: ~1 month

Eligibility
Key inclusion criteria
- 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
Minimum age
18 Years
Maximum age
50 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
- 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

- Consumption of red wine, seville oranges, grapefruit or grapefruit juice and/or
pummelos, exotic citrus fruits, grapefruit hybrids or fruit juices from 7 days prior
to the first dose of study medication.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


Intervention assignment
Crossover
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Terminated
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
11/12/2008
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
30/03/2009
Sample size
Target
Accrual to date
Final
12
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
GSK Investigational Site - Melbourne
Recruitment postcode(s) [1] 0 0
3004 - Melbourne

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
GlaxoSmithKline
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT00811356
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
GSK Clinical Trials
Address 0 0
GlaxoSmithKline
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT00811356