A study investigating the pain-relieving effects of a new drug in healthy adults

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Trevena Inc.

Participant type

Healthy volunteers

Age range

18-64 years

Gender

Male and Female

Therapeutic area

Diseases [C] - Nervous System Diseases [C10]

Trial duration

17 Nov 2022 → 21 Jun 2023

Decision date (initial)

2022-11-15

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

Yes

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Pharmacokinetic, Pharmacodynamic, Safety, Efficacy

To evaluate the analgesic effects of TRV045 using PainCart (including UVB burn inflammatory model)

Secondary objectives 2

1. To evaluate the safety and tolerability of TRV045
2. To evaluate the pharmacokinetic (PK) properties of TRV045

Conditions and MedDRA coding

Acute and chronic neuropathic pain secondary to diabetic peripheral neuropathy

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 5

1. Subjects between ≥ 18 and ≤ 55 years of age.
2. BMI ≥ 18.0 and ≤ 32.0 kg/m2, and body weight ≥ 50 kg, at screening.
3. Females of childbearing potential must agree to use highly effective method of contraception surgical sterilization (e.g., bilateral tubal ligation), or any 2 barrier methods (a combination of male condom and female condom with diaphragm, sponge, cervical cap or intrauterine device [IUD], hormonal contraception) from screening through 180 days after administration of the last dose of investigational product (IP).The combination of a male condom and female condom only is not allowed.
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 IP, and their partners must be willing to use a highly effective method of contraception (e.g., IUD, diaphragm with spermicide, oral contraceptive, injectable progesterone, subdermal implant, or tubal ligation) from screening through 90 days after administration of the last dose of IP.
5. Subjects must agree to not donate sperm from screening through 90 days, after administration of the last dose of IP.

Exclusion criteria 5

1. 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.
2. History of a significant respiratory condition (e.g., asthma, chronic obstructive pulmonary disease [COPD], chronic sinusitis, or bronchitis).
3. History or presence of conditions (including active viral or bacterial infection) that may place the subject at increased risk as determined by the investigator.
4. History of surgery or major trauma within 12 weeks of screening, or surgery planned during the study involvement period.
5. History of alcohol abuse, illicit drug use, physical dependence to any opioid, or any history of drug abuse or addiction within 12 months of screening.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Pharmacodynamic measurements with the UVB pain model

Secondary endpoints 2

1. Pharmacokinetic endpoints
2. Safety and tolerability endpoints

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

CHDR

Public contact point

Organisation

Trevena Inc.

Contact name

CHDR

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

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