A study investigating the safety, tolerability, absorption, excretion and effects of a new drug for the treatment of epilepsy.

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Trevena Inc.

Participant type

Healthy volunteers

Age range

18-64 years

Gender

Male

Therapeutic area

Diseases [C] - Nervous System Diseases [C10]

Trial duration

3 Feb 2023 → 9 Jun 2023

Decision date (initial)

2023-01-31

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

Funding sources

Trevena Inc.

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Pharmacodynamic, Safety, Pharmacokinetic, Others

To evaluate how TRV045 affects the ability of the brain cells to conduct electrical stimulation (cortical excitability) in healthy male adults.

Conditions and MedDRA coding

Epilepsy

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 6

1. Signed informed consent prior to any study-mandated procedure.
2. Male subjects between ≥ 18 and ≤ 55 years of age.
3. Body Mass Index (BMI) ≥ 18.0 and ≤ 32.0 kg/m2, and body weight ≥ 50 kg, at screening.
4. Males who are sexually active and whose partners are females of childbearing potential must agree to use condoms from screening through 90 days after administration of the last dose of IMP, and their partners must be willing to use a highly effective method of contraception (e.g., intrauterine device [IUD], diaphragm with spermicide, oral contraceptive, injectable progesterone, subdermal implant, or tubal ligation).
5. Subjects must agree to not donate sperm from screening through 90 days after administration of the last dose of IMP.
6. Subjects must be able to communicate effectively (in Dutch) with the study personnel and must be willing to comply with the requirements of the study.

Exclusion criteria 5

1. Evidence of any acute (at screening or prior to first dose) or chronic disease or condition that could interfere with, or for which the treatment might interfere with, the conduct of the study, or that would pose an unacceptable risk to the subject in the opinion of the investigator (following a detailed medical history, physical examination, VSs [systolic and diastolic BP, PR, body temperature] and 12-lead ECG). Minor deviations from the normal range may be accepted, if judged by the Investigator to have no clinical relevance.
2. History or presence of conditions which, in the judgment of the investigator, are known to interfere with the absorption, distribution, metabolism, or excretion of drugs
3. History or presence of any condition that, in the judgment of the investigator, might increase the risk (or worsening) of infection, including but not limited to an active viral or bacterial infection, respiratory condition (e.g., asthma, chronic obstructive pulmonary disease, chronic sinusitis, or bronchitis), recent surgery or major trauma (within 12 weeks of screening), or surgery planned during the study period.
4. History or presence of conditions which, in the judgment of the investigator, might increase the risk of performing TMS, including but not limited to epilepsy or febrile seizures, intracranial mass lesion, hydrocephalus, clinically significant head injury or trauma, metal objects in the brain or skull, cochlear implant or a deep brain stimulation device.
5. Any condition that could interfere with the quality of or ability to perform TMS, such as an abnormal sleeping pattern (e.g., working night shifts), dreadlocks or hairpieces that cannot be removed or a rMT of more than 75% of the maximum stimulator output as measured using TMS-EMG during screening.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Change from baseline in Motor Evoked Potential: • Peak-to-peak amplitude (μV)

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Placebo 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Trevena Inc.

Sponsor organisation

Trevena Inc.

Address

955 Boulevard Suite 110

City

Chesterbrook

Postcode

19087-5627

Country

United States

Scientific contact point

Organisation

Trevena Inc.

Contact name

Centre for Human Drug Research

Public contact point

Organisation

Trevena Inc.

Contact name

Centre for Human Drug Research

Locations

1 EU/EEA country · 1 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Summary of results Art. 37(4) CTR

Layperson summary Annex V

Documents 2 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

3 submissions — initial application plus substantial / non-substantial modifications