Last updated: 11/07/2018 03:16:55
A First Time in Human Study in Healthy Volunteers to Investigate a New Medicine to Treat MalariaN/A
Clinicaltrials.gov ID
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Other
Other
Trial overview
Official 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
Trial description: 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.
Primary purpose:
Treatment
Trial design:
Crossover Assignment
Masking:
Single (Participant)
Allocation:
Randomized
Primary outcomes:
Evidence of safety as determined by assessing adverse events, vital signs, spirometry, ECGs, telemetry, renal biomarkers, safety labs, and physical examination
Timeframe: Part A: 3-4 months; Part B: ~1 month
Secondary outcomes:
Plasma or blood concentrations of study drug
Timeframe: Part A: 3-4 months; Part B: ~1 month
Interventions:
Enrollment:
12
Primary completion date:
Not applicable
Observational study model:
Not applicable
Time perspective:
Not applicable
Clinical publications:
José M. Bueno, Esperanza Herreros, Iñigo Angulo-Barturen, Santiago Ferrer, José M. Fiandor, Francisco J. Gamo, Domingo Gargallo-Viola & Geo Derimanov. Exploration of 4(1H)-pyridones as a novel family of potent Antimalarials inhibitors of the Plasmodial Cytochrome bc1. Fut Med Chem. 2012;4(18):2311-2323.
Medical condition
Malaria
Product
GSK932121, rosiglitazone
Collaborators
Not applicable
Study date(s)
December 2008 to March 2009
Type
Interventional
Phase
1
Participation criteria
Sex
Female & Male
Age
18 - 50 years
Accepts healthy volunteers
Yes
- 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
- Positive pre-study drug/alcohol screen
- Positive pre-study Hepatitis B surface antigen or positive Hepatitis C antibody result within 3 months of screening.
Inclusion and exclusion criteria
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
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.
Trial location(s)
Location
GSK Investigational Site
Melbourne, Victoria, Australia, 3004
Status
Terminated/Withdrawn
Study documents
Clinical study report
Available language(s): English
Scientific result summary
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Refer to study documents
Recruitment status
Other
Actual primary completion date
Not applicable
Actual study completion date
2009-30-03
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
Additional information about the trial
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Additional information
Results for study 111319 can be found on the GSK Clinical Study Register.
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