nerve pain (peripheral neuropathic pain) nerve pain peripheral neuropathic pain
Conditions
Interventions
Part A:
The planned dose levels for the study are as follows:
Group Day Treatment* How often
A1 1 CFTX-1554 30 mg* (3 participants) or placebo (2 participants) once
A2 1 CFTX-1554 90 mg* (3 participa
Sponsors
Confo Therapeutics
Eligibility
Age
18 Years to 64 Years
Inclusion criteria
Inclusion criteria: 1. Sex: male or female. 2. Age: Part A and B - 18 to 55 years, inclusive, at screening. Part C - 18 to 35 years, inclusive, at screening 3. Body mass index (BMI): 18.0 to 30.0 kg/m2, inclusive, at screening. 4. At screening, females may be of childbearing potential but not pregnant or lactating, or they may be of nonchildbearing potential (either surgically sterilized or physiologically incapable of becoming pregnant, or at least 1 year postmenopausal [amenorrhea duration of 12 consecutive months]); nonpregnancy will be confirmed for all females by a serum pregnancy test conducted at screening, (each) admission, and at follow-up. 5. Female subjects of childbearing potential who have a fertile male sexual partner must agree to use adequate contraception from at least 4 weeks prior to (first) administration of the study drug until 90 days after the follow up visit. Adequate contraception is defined as using hormonal contraceptives or an intrauterine device combined with at least 1 of the following forms of contraception: a diaphragm, a cervical cap, or a condom. Total abstinence from heterosexual intercourse, in accordance with the lifestyle of the subject, is also acceptable. Further criteria apply
Exclusion criteria
Exclusion criteria: 1. Previous participation in the current study. 2. History of relevant drug and/or food allergies. 3. Allergy or hypersensitivity to active ingredient or excipients.. 4. Using nicotine-containing products within 60 days prior to (the first) drug administration. 5. History of alcohol abuse or drug addiction (including soft drugs like cannabis products) within 1 year prior to screening. Further criteria apply
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To assess the safety and tolerability of single and multiple ascending oral doses of CFTX-1554 in healthy subjects | — |
Secondary
| Measure | Time frame |
|---|---|
| To assess the PK of single and multiple ascending oral doses of CFTX-1554 in healthy subjects, including the exposure after intake with food (high-fat breakfast) in comparison with intake fasted, and after intake as capsule in comparison with intake as liquid formulation (1 dose level only) Exploratory To explore the effect of AT2R inhibition on the capsaicin-induced dermal blood flow response in healthy subjects using 3 single-dose levels (low-, mid-, and high-dose) of CFTX-1554 | — |
Countries
Netherlands
Outcome results
None listed