Crossover Study to Evaluate the ECG Effects of Telaglenastat in Adults
Research type
Research Study
Full title
A Three-Way Crossover Study to Evaluate the ECG Effects of Telaglenastat in Healthy Adult Subjects
IRAS ID
286709
Contact name
Sunu Valasseri
Contact email
Sponsor organisation
Calithera Biosciences, Inc.
Eudract number
2020-003189-38
Duration of Study in the UK
0 years, 2 months, 16 days
Research summary
Summary of Research
Telaglenastat (also known as CB-839) is an investigational drug for the treatment of certain types of cancer. It has been tested in clinical studies up to a dose of 1000 mg three times a day in fasting state and 1000 mg two times a day in fed state.
The main purpose of the study is to assess the effects of telaglenastat on the electrical activity of the heart.
This will be a multiple-dose, randomized, double-blind (with respect to telaglenastat and placebo (dummy drug)), placebo- and positive( moxifloxacin will be used as positive control drug)-controlled, 3-way crossover thorough QT (TQT) study in healthy adult subjects.
The study will have three treatment periods separated by 5 days. The three treatments are described as below.
Treatment A:(Therapeutic dose)
800 mg telaglenastat (4 x 200 mg tablets) administered twice daily (BID) on Days 1-3, with a single dose administered on the morning of Day 4.Treatment B:(Placebo control)
Telaglenastat matching placebo (4 x matching placebo tablets) administered BID on Days 1-3, with a single dose administered on the morning of Day 4.Treatment C:(Positive control)
Single dose of 400 mg moxifloxacin (1 x 400 mg tablet) administered on the morning of Day 4.All study drugs will be administered following a high-fat meal. All study drugs will be administered orally with approximately 240 mL of water.
Screening of subjects will occur within 28 days prior to the first dosing.
Thirty (30) healthy adult male and female subjects will be enrolled.In Treatments A and B, subjects will receive the assigned treatment on Day 1 through the morning of Day 4. In Treatment C, subjects will receive a single-dose administration of moxifloxacin in the morning of Day 4. There will be a washout period of at least 5 days between the last dose of a period and the first dose of the next period.
Summary of Results
Telaglenastat (also known as CB-839) is a potent inhibitor of the enzyme glutaminase. It is being developed for the treatment of cancer in humans. To support this development, the cardiovascular safety of the compound is being evaluated in this study in 30 healthy adult male and female subjects. Regulatory guidance has emphasized the need to obtain clear robust data on the effect of new chemical entities on the heart rate and electrocardiogram (ECG). The therapeutic dose of 800 mg telaglenastat or placebo twice a day was administered to healthy human subjects for 3 days, after which the ECG was evaluated in each subject. Telaglenastat at the studied dose had no clinically relevant effect on heart rate. No clinically significant ECG changes were observedREC name
HSC REC B
REC reference
20/NI/0094
Date of REC Opinion
13 Aug 2020
REC opinion
Favourable Opinion