No registrations found.
ID
Source
Health condition
Healthy human volunteers (preliminary safety study)
Cancer
Sponsors and support
PRA Health Sciences located at Van Swietenlaan 6, 9728 NZ Groningen, in The Netherlands.
Intervention
Outcome measures
Primary outcome
Safety and tolerability of single and multiple oral ascending doses of FLX475 administered to healthy male and female subjects
Secondary outcome
Pharmacokinetics of FLX475 (capsule and tablet formulation)
Food effect
Background summary
This study is a first-in-human, 2-part, single-center, Phase 1, randomized, double-blind, placebo-controlled study in up to 136 healthy male and female subjects of FLX475. FLX475 is an orally-available, potent, and selective antagonist of CCR4, a chemokine receptor found on the surface of regulatory T cells responsible for their recruitment into the tumor microenvironment. In preclinical models of cancer, FLX475 has been shown to inhibit the recruitment of regulatory T cells into tumors, and to improve tumor control and eradication in combination with checkpoint inhibitor drugs. This first-in-human study will examine the safety, pharmacokinetics, and pharmacodynamics in healthy volunteers of single and repeat dosing. It will also examine the relative bioavailability of an alternative tablet formulation, and food effect on PK.
Study design
Throughout the study
Intervention
FLX475
Inclusion criteria
Healthy Male or Female
18-55 years of age, inclusive
At least 50 kg in weight
BMI: 18.0-30.0 kg/m2, inclusive
Non-smoking
Exclusion criteria
Use of tobacco products within 60 days prior to drug administration
History of alcohol abuse or drug addiction
Positive drug and alcohol screen
Participation in a drug study within 60 days prior to drug administration
Donation or loss of more than 100 mL of blood within 60 days prior to drug administration. Donation or loss of more than 1.5 liters of blood (for male subjects) / more than 1.0 liters of blood (for female subjects) in the 10 months prior to drug administration.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL7240 |
| NTR-old | NTR7439 |
| Other | EudraCT number: 2017-003952-22 (Stichting BEBO) : FLX475-01 |