Status:
COMPLETED
A Study of Parenterally-administered Teverelix TFA in Healthy Male Volunteers
Lead Sponsor:
Antev Ltd.
Conditions:
Healthy
Eligibility:
MALE
40-70 years
Phase:
PHASE1
Brief Summary
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 subcutan...
Detailed Description
The primary objective of the study is: • To characterise the pharmacokinetic (PK) profile of teverelix following single dose, subcutaneous (s.c.) and intramuscular (i.m.) administration of teverelix ...
Eligibility Criteria
Inclusion
- Provide voluntarily agreement to participate in this study and sign an Independent Ethics Committee (IEC)-approved informed consent prior to performing any of the screening procedures.
- Males of any ethnic origin, between 40 to 70 years of age (inclusive) at the screening visit.
- Healthy, determined by pre-study medical evaluation (medical history, vital signs, physical examination, standard 12-lead ECG and clinical laboratory evaluations).
- If a vital sign or ECG assessment is outside of the reference range at the screening visit or admission, the assessment may be repeated once to rule out any error.
- Body mass index (BMI) between 20.0 and 34.9 kg/m2 (inclusive) at the screening visit and on admission.
Exclusion
- Clinically relevant history of cardiovascular, respiratory, hepatic, renal, pancreatic, gastrointestinal, metabolic, endocrine, neurological, dermatological, immunological, psychiatric or other diseases/disorders as determined by the Principal Investigator or designee, or evidence of such diseases/disorders during the screening period.
- Any disorder or clinically relevant surgical history that would interfere with the absorption, distribution, metabolism or excretion of the study drug.
- History of proneness to orthostatic dysregulation, fainting or blackouts.
- History or physical evidence of chronic or clinically relevant acute infection.
- Screening total testosterone \<3.0 ng/mL (\<10.4 nmol/L).
- History of anaphylactoid reactions or hypersensitivity to teverelix or GnRH antagonists or any of the excipients of the products tested.
- History of clinically relevant allergies or idiosyncrasies to medication or food.
- History of regular alcohol consumption exceeding 21 units per week within 2 years of study entry.
- History of illicit drug abuse within 2 years of study entry.
- Any ECG abnormality of clinical relevance; ECG QT interval corrected for heart rate using Fridericia's correction (QTcF) \> 450 ms at the screening visit.
- Any clinically relevant findings in the laboratory tests, as judged by the Principal Investigator, at the screening visit and on admission; alanine aminotransferase (ALT) \> 1.5 x the upper limit of normal (ULN) and/or aspartate aminotransferase (AST) \> 1.5 x ULN and/or total bilirubin \> 1.0 x ULN, as confirmed by subsequent repeat assessment, at the screening visit and on admission. If a laboratory assessment is outside of the reference range at the screening visit or admission, the assessment may be repeated once to rule out laboratory error.
- An estimated glomerular filtration rate (eGFR) \< 90 mL/min, based on creatinine clearance calculation by the Cockcroft Gault formula and normalised to an average surface area of 1.73m2, at the screening visit.
- Positive results in any of the tests for hepatitis B surface antigen (HBsAg), total hepatitis B core antibody (HBcAb), hepatitis C antibody (anti-HCV) or human immunodeficiency virus (HIV) antibodies, at the screening visit.
- Positive urine test for ethanol and/or drugs of abuse at the screening visit or admission.
- Use of prescription, non-prescription and over-the-counter (OTC) medications (including vitamins or herbal remedies) within 2 weeks prior to dosing is prohibited.
- Receiving an investigational product in a clinical trial within 3 months prior to the screening visit.
- Donation of blood (\> 500 mL) or blood products within 2 months (56 days) prior to the screening visit.
- Unwilling to avoid consumption of coffee and caffeine-containing products within 48 hours prior to admission until discharge from the study centre, as well as from 48 hours before ambulatory visits.
- Unwilling to avoid use of alcohol or alcohol-containing foods, medications or beverages, within 48 hours prior to admission until discharge from the study centre, as well as from 48 hours before ambulatory visits.
- Unwilling to abstain from vigorous exercise from 72 hours prior to admission until discharge from the study centre, as well as from 72 hours before ambulatory visits.
- Unable to understand the protocol requirements, instructions and study related restrictions, the nature, scope and possible consequences of the clinical study.
- Subject is unlikely to comply with the protocol requirements, instructions and study related restrictions; e.g., uncooperative attitude, inability to return for follow-up visits and improbability of completing the clinical study.
- Subject has any concurrent condition that, in the opinion of the Principal Investigator, would make the subject unsuitable for participation in the clinical study.
- Subject is an employee or the close relative of an employee of the Sponsor or the clinical research organisation (CRO) involved in the clinical study.
- Vulnerable subjects defined as individuals whose willingness to volunteer in a clinical study may be unduly influenced by the expectation, whether justified or not, of benefits associated with participation, or of a retaliatory response from senior members of a hierarchy in case of refusal to participate (e.g., persons in detention, minors and those incapable of giving consent).
Key Trial Info
Start Date :
November 19 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 16 2020
Estimated Enrollment :
48 Patients enrolled
Trial Details
Trial ID
NCT03781947
Start Date
November 19 2018
End Date
March 16 2020
Last Update
March 17 2020
Active Locations (1)
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1
PAREXEL International Early Phase Clinical Unit (EPCU)
London, Middlesex, United Kingdom, HA1 3UJ