ID
Bron
Aandoening
Healthy human volunteers (preliminary safety study)
Cancer
Ondersteuning
PRA Health Sciences located at Van Swietenlaan 6, 9728 NZ Groningen, in The Netherlands.
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
Safety and tolerability of single and multiple oral ascending doses of FLX475 administered to healthy male and female subjects
Achtergrond van het onderzoek
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.
Onderzoeksopzet
Throughout the study
Onderzoeksproduct en/of interventie
FLX475
Publiek
Wetenschappelijk
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
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
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
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.
Opzet
Deelname
Opgevolgd door onderstaande (mogelijk meer actuele) registratie
Geen registraties gevonden.
Andere (mogelijk minder actuele) registraties in dit register
Geen registraties gevonden.
In overige registers
| Register | ID |
|---|---|
| NTR-new | NL7240 |
| NTR-old | NTR7439 |
| Ander register | EudraCT number: 2017-003952-22 (Stichting BEBO) : FLX475-01 |