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

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 - IFM 2427 SAD MAD FE study to investigate safety, PK and PD

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON49211

Enrollment

136

Registered

2019-01-16

Start date

2019-02-27

Completion date

Unknown

Last updated

2025-08-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Crohns disease Inflammatory diseases

Interventions

Part A: IFM-2427 or placebo will be given once, as an oral drink. After administration of the study compound, the vial will be rinsed twice with water which the volunteer will also be required to dr

we call this a double-blinded study. However, if it is important for the volunteers health, for example in case of a serious side effect, this information can be looked up during the study. For sa

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

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

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.

Design outcomes

Primary

Measure	Time frame
Safety : Adverse events (AEs), clinical laboratory, vital signs, 12-lead electrocardiogram (ECG), 24 hour Holter monitoring and physical examination Pharmacokinetics : Plasma concentrations of IFM 2427, and plasma PK parameters estimated using noncompartmental analysis (NCA), as appropriate: Cmax, tmax, AUC0-last, AUC0 inf, t1/2, CL/F, and Vz/F (single-dose PK; Parts A, B, and D), Cmax, tmax, AUC0-, t1/2, CLss/F, Vzss/F, Rac,AUC, and Rac,Cmax (multiple-dose PK; Part C) Metabolite profiling in plasma samples taken from subjects of Group 2 in Part C Urine IFM 2427 concentrations and urine PK parameters including, but not limited to: Ae0-, Fe0-*, and CLr (Part C)	—

Measure

Time frame

Safety : Adverse events (AEs), clinical laboratory, vital signs, 12-lead electrocardiogram (ECG), 24 hour Holter monitoring and physical examination Pharmacokinetics : Plasma concentrations of IFM 2427, and plasma PK parameters estimated using noncompartmental analysis (NCA), as appropriate: Cmax, tmax, AUC0-last, AUC0 inf, t1/2, CL/F, and Vz/F (single-dose PK; Parts A, B, and D), Cmax, tmax, AUC0-*, t1/2, CLss/F, Vzss/F, Rac,AUC, and Rac,Cmax (multiple-dose PK; Part C) Metabolite profiling in plasma samples taken from subjects of Group 2 in Part C Urine IFM 2427 concentrations and urine PK parameters including, but not limited to: Ae0-*, Fe0-*, and CLr (Part C)

—

Secondary

Measure	Time frame
Pharmacodynamics : PD parameters and exploratory biomarkers: - Blood cell release of IL-1β and IL-18 following ex vivo stimulation with an activator of the NLRP3 inflammasome compared to control conditions (Parts A and C) - Exploratory PD (possible analyses of ribonucleic acid [RNA] transcriptomics and proteomics in the future) (Parts A and C) - Potential induction of CYP3A due to IFM-2427 based on calculating whether a change from baseline in the plasma 4β hydroxycholesterol/cholesterol ratio is observed (Part C) Pharmacogenomics : Sequencing of deoxyribonucleic acid (DNA) isolated from whole blood may be performed to: - Determine carriers of clonal hematopoiesis of indeterminate potential based on a pre-specified list of variants in up to 100 genetic loci - Genotype the NLRP3 genetic locus - Genotype loci related to NLRP3 signalling - Analysis of whole-exome or whole genome sequencing derived variants	—

Measure

Time frame

Pharmacodynamics : PD parameters and exploratory biomarkers: - Blood cell release of IL-1β and IL-18 following ex vivo stimulation with an activator of the NLRP3 inflammasome compared to control conditions (Parts A and C) - Exploratory PD (possible analyses of ribonucleic acid [RNA] transcriptomics and proteomics in the future) (Parts A and C) - Potential induction of CYP3A due to IFM-2427 based on calculating whether a change from baseline in the plasma 4β hydroxycholesterol/cholesterol ratio is observed (Part C) Pharmacogenomics : Sequencing of deoxyribonucleic acid (DNA) isolated from whole blood may be performed to: - Determine carriers of clonal hematopoiesis of indeterminate potential based on a pre-specified list of variants in up to 100 genetic loci - Genotype the NLRP3 genetic locus - Genotype loci related to NLRP3 signalling - Analysis of whole-exome or whole genome sequencing derived variants

—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)