HealthyPhase 1NCT03781947
A Study of Parenterally-administered Teverelix TFA in Healthy Male Volunteers
A Phase 1 study testing teverelix TFA in people with Healthy, run by Antev Ltd. at 1 site in United Kingdom.
Trial 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 subcutaneous or intramuscular route of administration in healthy male volunteers Read more about this study
- Who is it for?
- Ages 40 to 70 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- teverelix TFA
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 19 Nov 2018to 16 Mar 2020
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 70 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 25Show fewer
- 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).
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
PAREXEL International Early Phase Clinical Unit (EPCU)
London, Middlesex, HA1 3UJ
About this study
Official title: A Phase I, Open-label, Single Centre Study Investigating the PK, Safety and PD of a Single Dose of Teverelix TFA, a GnRH Antagonist, Via s.c. or i.m. Route of Administration in Healthy Male Volunteers
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
Read the 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 TFA in healthy male subjects
The secondary objectives of the study are:
- To assess the safety and tolerability of teverelix TFA after single s.c. and i.m. injections in healthy male subjects
- To evaluate pharmacodynamics (PD) effects of teverelix following single dose, s.c. and i.m. administration of teverelix TFA in healthy male subjects
- Conditions
- Healthy
- Being tested
- teverelix TFA
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
teverelix TFADrug
A single s.c. or i.m. injection of teverelix TFA administered on Day 1
| Study group | Role | What they receive |
|---|---|---|
| 90 mg s.c. | Experimental | A single s.c. injection of 90 mg teverelix TFA administered on Day 1 Receives: Drug: teverelix TFA |
| 60 mg s.c. | Experimental | A single s.c. injection of 60 mg teverelix TFA administered on Day 1 Receives: Drug: teverelix TFA |
| 90 mg i.m. | Experimental | A single i.m. injection of 90 mg teverelix TFA administered on Day 1 Receives: Drug: teverelix TFA |
| 120 mg s.c. | Experimental | A single s.c. injection of 120 mg teverelix TFA administered on Day 1 Receives: Drug: teverelix TFA |
What is being measured
The primary outcome is the main question the study is designed to answer.
AUC0-t
Area under the concentration time-curve from time zero up to the last measurable concentration at time point t Area under the concentration time-curve from time zero up to the last measurable concentration at time point t Area under the concentration time-curve from time zero up to the last measurable concentration at time point t
Measured: 12 weeks
AUC0-t1
Area under the concentration time-curve from time zero up to concentration at time point t1 after which the concentrations start to rise again towards a second peak, t1 will be determined after review of the concentration-time profiles (immediate release component of total observed AUC)
Measured: 12 weeks
AUCt1-t
Area under the concentration time-curve from time point t1 up to time point t (slow release component of total observed AUC)
Measured: 12 weeks
AUC0-∞
Area under the concentration time-curve from time zero up to infinity (∞)
Measured: 12 weeks
Cmax
Maximum observed concentration after administration
Measured: 12 weeks
Cmax,0-t1
Maximum observed concentration after administration from zero up to time point t1
Measured: 12 weeks
Cmax,t1-t
Maximum observed concentration after administration from time point t1 up to time point t
Measured: 12 weeks
Tmax
Time to reach Cmax after dosing
Measured: 12 weeks
Tmax,0-t1
Time to reach Cmax,0-t1 after dosing
Measured: 12 weeks
Tmax,t1-t
Time to reach Cmax,t1-t after dosing
Measured: 12 weeks
λz
Apparent terminal rate constant
Measured: 12 weeks
t½
Apparent terminal plasma half-life
Measured: 12 weeks
Secondary outcomes (4)
Systemic tolerability - Incidence of Treatment-Emergent Adverse Events
Systemic tolerability assessed by incidence of treatment emergent AEs (TEAEs)
Measured: 12 weeks
Local tolerability - Standardised Injection Site Reaction Scoring System (4-point) plus photography
The injections sites will be assessed (score 0 = none; 1 = mild; 2 = moderate; 3 = severe and undesirable) for signs of erythema, swelling, bruising, itching, pain and other signs of local reactions. Subjects will be monitored for duration of symptoms, sequelae and impact on activities of daily living (ADL). Photographs of all injection sites will be taken at all study visits post-administration
Measured: 12 weeks
Cardiac assessments
The following 12-lead ECG parameters will be assessed: PR interval, QRS interval, RR interval, QT interval and QTc interval (QTcF)
Measured: 12 weeks
24 hour Holter monitoring
Triplicate 10 second 12-lead ECGs will be extracted at time points prior to PK sampling times (Day 1) and matched timepoints (Day -1) in order to facilitate concentration-QTc effect modelling
Measured: Day -1 to Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2018
- Study start19 Nov 2018
- Primary completion16 Mar 2020
- Study completion16 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- This Phase I clinical study is an open-label, parallel-design, single-centre study to investigate the PK, safety and PD following subcutaneous and intramuscular administration of single doses of teverelix TFA in healthy male subjects.
- Masking
- None (open label)
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Antev Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pablo Forte Soto, MD, Principal investigator, Parexel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03781947
- Sponsor's protocol ID
- ANT-1111-P01
- Status last verified
- Mar 2020
- First submitted
- 19 Nov 2018
- Last updated
- 17 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I, Open-label, Single Centre Study Investigating the PK, Safety and PD of a Single Dose of Teverelix TFA, a GnRH Antagonist, Via s.c. or i.m. Route of Administration in Healthy Male Volunteers
- ClinicalTrials.gov ID
- NCT03781947
- Acronym / sponsor ID
- ANT-1111-P01
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Antev Ltd.Industry (pharma, biotech, devices)
- Study start
- 19 Nov 2018 (actual)
- Primary completion
- 16 Mar 2020 (actual)
- Study completion
- 16 Mar 2020 (actual)
- First posted
- 20 Dec 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 TFA in healthy male subjects
The secondary objectives of the study are:
- To assess the safety and tolerability of teverelix TFA after single s.c. and i.m. injections in healthy male subjects
- To evaluate pharmacodynamics (PD) effects of teverelix following single dose, s.c. and i.m. administration of teverelix TFA in healthy male subjects
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- This Phase I clinical study is an open-label, parallel-design, single-centre study to investigate the PK, safety and PD following subcutaneous and intramuscular administration of single doses of teverelix TFA in healthy male subjects.
| Arm | Type | Receives |
|---|---|---|
| 90 mg s.c. | Experimental | Drug: teverelix TFAA single s.c. injection of 90 mg teverelix TFA administered on Day 1 |
| 60 mg s.c. | Experimental | Drug: teverelix TFAA single s.c. injection of 60 mg teverelix TFA administered on Day 1 |
| 90 mg i.m. | Experimental | Drug: teverelix TFAA single i.m. injection of 90 mg teverelix TFA administered on Day 1 |
| 120 mg s.c. | Experimental | Drug: teverelix TFAA single s.c. injection of 120 mg teverelix TFA administered on Day 1 |
Who may qualify
- Ages
- 40 to 70 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (25 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| teverelix TFAA single s.c. or i.m. injection of teverelix TFA administered on Day 1 | Drug | 120 mg s.c., 60 mg s.c., 90 mg i.m., 90 mg s.c. |
Primary outcome
AUC0-t
Time frame: 12 weeks
Area under the concentration time-curve from time zero up to the last measurable concentration at time point t Area under the concentration time-curve from time zero up to the last measurable concentration at time point t Area under the concentration time-curve from time zero up to the last measurable concentration at time point t
AUC0-t1
Time frame: 12 weeks
Area under the concentration time-curve from time zero up to concentration at time point t1 after which the concentrations start to rise again towards a second peak, t1 will be determined after review of the concentration-time profiles (immediate release component of total observed AUC)
AUCt1-t
Time frame: 12 weeks
Area under the concentration time-curve from time point t1 up to time point t (slow release component of total observed AUC)
AUC0-∞
Time frame: 12 weeks
Area under the concentration time-curve from time zero up to infinity (∞)
Cmax
Time frame: 12 weeks
Maximum observed concentration after administration
Cmax,0-t1
Time frame: 12 weeks
Maximum observed concentration after administration from zero up to time point t1
Cmax,t1-t
Time frame: 12 weeks
Maximum observed concentration after administration from time point t1 up to time point t
Tmax
Time frame: 12 weeks
Time to reach Cmax after dosing
Tmax,0-t1
Time frame: 12 weeks
Time to reach Cmax,0-t1 after dosing
Tmax,t1-t
Time frame: 12 weeks
Time to reach Cmax,t1-t after dosing
λz
Time frame: 12 weeks
Apparent terminal rate constant
t½
Time frame: 12 weeks
Apparent terminal plasma half-life
4 secondary outcomes
Systemic tolerability - Incidence of Treatment-Emergent Adverse Events
Time frame: 12 weeks
Local tolerability - Standardised Injection Site Reaction Scoring System (4-point) plus photography
Time frame: 12 weeks
Cardiac assessments
Time frame: 12 weeks
24 hour Holter monitoring
Time frame: Day -1 to Day 1
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pablo Forte Soto, MD principal investigator
Parexel
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing teverelix TFA in people with Healthy, run by Antev Ltd. at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
AUC0-t (time frame: 12 weeks). The study lists 12 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Mar 2020.