Investigating pharmacokinetics, safety & pharmacodynamics of Teverelix
Research type
Research Study
Full title
A Phase I, open-label, single centre study investigating the pharmacokinetics, safety and pharmacodynamics of a single dose of teverelix TFA, a gonadotrophin releasing hormone antagonist, via subcutaneous or intramuscular route of administration in healthy male volunteers
IRAS ID
252245
Contact name
Pablo ForteSoto
Contact email
Sponsor organisation
Antev Ltd
Eudract number
2018-002472-41
Duration of Study in the UK
0 years, 6 months, 0 days
Research summary
This is an open-label, parallel-design, single-centre study to investigate the safety, pharmacokinetics (PK) and pharmacodynamics (PD) of teverelix TFA in healthy male subjects. PK refers to how the study drug is absorbed (taken up into the body), metabolised (chemically broken down), distributed through the body, and excreted (removed from the body). PD refers to the biological effects of the study drug and the way in which the study drug works (mechanism of action).
Four treatment groups of 12 subjects each are planned. In each treatment group subjects will receive a single dose of study drug, either subcutaneously (s.c.) or intramuscularly (i.m.). Per subject, the study will have a screening period of up to 28 days, a treatment period of up to 12 weeks (including an in-house stay of maximum 4 days and 3 nights), and a final assessment to ensure subject safety before study completion. The planned doses of 60 mg (Treatment Group 3, s.c.), 90 mg (Treatment Groups 1, s.c. and 2, i.m.),and 120 mg (Treatment Group 4, s.c.) are expected to be well tolerated based on the safety profile of teverelix TFA obtained from previous studies,doses of up to 540 mg teverelix TFA have been dosed sc over a 3 day period to prostate cancer patients with no safety concerns being noted.
Teverelix TFA was developed as treatment of hormone-sensitive tumours of the prostate, as well as for non-malignant indications such as benign prostatic hyperplasia(BPH). To date, results from 13 clinical studies on teverelix are available, with no ongoing studies. Since the last clinical trial with teverelix TFA was conducted(2008)advances have been made in bioanalytical and analytical methodologies. New drug product manufacturers are now involved. In addition, improved understanding of the physicochemical properties of teverelix TFA now allow for better control of the absolute amount and nature of the drug product that is administered to trial subjects.
REC name
South Central - Berkshire Research Ethics Committee
REC reference
18/SC/0487
Date of REC Opinion
24 Sep 2018
REC opinion
Favourable Opinion