A phase 1, double-blind placebo-controlled single and multiple ascending dose study of the safety, tolerability, pharmacokinetics, pharmacodynamics and food effects of IFM-2427 in healthy subjects
Completed
- Conditions
- Crohns diseaseInflammatory diseases10017969
- Registration Number
- NL-OMON49211
- Lead Sponsor
- IFM Therapeutics
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 136
Inclusion Criteria
- Gender : male or female; females must be of non-childbearing potential
- Age : 18 to 64 years, inclusive, at screening.
- Body mass index (BMI) : 18.5 to 30.0 kg/m2 at screening.
- Weight : >=50 kg at screening.
Exclusion Criteria
Suffering from hepatitis B, hepatitis C, cancer or HIV/AIDS. In case of
participation in another drug study within 90 days before the start of this
study or being a blood donor within 60 days from the start of the study. In
case of donating more than 1.5 liters of blood in the 10 months prior the start
of this study.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Safety : Adverse events (AEs), clinical laboratory, vital signs, 12-lead<br /><br>electrocardiogram (ECG), 24 hour Holter monitoring and physical examination<br /><br>Pharmacokinetics : Plasma concentrations of IFM 2427, and plasma PK parameters<br /><br>estimated using noncompartmental analysis (NCA), as appropriate: Cmax, tmax,<br /><br>AUC0-last, AUC0 inf, t1/2, CL/F, and Vz/F (single-dose PK; Parts A, B, and D),<br /><br>Cmax, tmax, AUC0-*, t1/2, CLss/F, Vzss/F, Rac,AUC, and Rac,Cmax (multiple-dose<br /><br>PK; Part C)<br /><br>Metabolite profiling in plasma samples taken from subjects of Group 2 in Part C<br /><br>Urine IFM 2427 concentrations and urine PK parameters including, but not<br /><br>limited to: Ae0-*, Fe0-*, and CLr (Part C)</p><br>
- Secondary Outcome Measures
Name Time Method