A Double-blind, Randomized, Placebo-controlled, Combined Single and Multiple Ascending Dose Study to Investigate the Safety, Tolerability and Pharmacokinetic Profile of IFB-088, in Healthy Volunteers
Sponsor study identifier
Secondary identifiers
EUDRACT_NUMBER
NIH
interventional
72
1 country
2
Study Start
June 21, 2018
Actual (reported)Primary Completion
June 21, 2019
Actual (reported)Study Completion
December 16, 2019
Actual (reported)This is the first study of single and multiple doses of IFB-088 in human subjects. The current study is designed to assess in the first part, the safety, tolerability, plasma and urine pharmacokinetics (PK) of single oral doses of IFB-088 in healthy subjects (Single Ascending Doses - SAD) and in a second part safety, tolerability, plasma and urine pharmacokinetics (PK) of multiple oral doses of IFB-088 in healthy subjects (Multiple Ascending Doses - MAD)
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 16, 2019
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
June 20, 2018
Actual (reported)June 21, 2018
Actual (reported)August 1, 2018
Actual (reported)June 21, 2019
Actual (reported)December 16, 2019
Actual (reported)January 26, 2022
Actual (reported)Number of Participants With Treatment Emergent Adverse Events Per Group
This safety outcome lists the number of subjects experiencing adverse events (AEs), whether not related, possibly or unlikely related to the study treatment. As all the parameters are developped in the pharmacovigilance section, please do refer to that section for further details.
SAD & MAD phases: Screening visit to End of study visit (7 to 14 days after last dosing) + 30 days
Number of Participants With Change in Concomitant Medications
SAD & MAD phases: Continuous (Screening visit to End of study visit (7 to 14 days after last dosing) + 30 days)
Pharmacokinetic: Maximum Observed Plasma Concentration (Cmax)
Starting 1 hour prior to dosing on Day 1 and until 72 hours after last dosing (Day 17)
Pharmacokinetic: Time to Reach the Maximum Concentration in Plasma (Tmax)
Starting 1 hour prior to dosing on Day 1 and until 72 hours after last dosing (Day 17)
Pharmacokinetic: Terminal Half-life (t1/2)
Starting 1 hour prior to dosing on Day 1 and until 72 hours after last dosing (Day 17)
Pharmacokinetic: Area Under Plasma Concentration-time Curve From Hour 0 to Last Sample With Measurable Plasma Concentrations (AUClast)
Starting 1 hour prior to dosing on Day 1 and until 72 hours after last dosing (Day 17)
SAD Exploratory Biomarkers Analysis
SAD phase: Day 1 at predose, 1.5 hours and 24 hours
MAD Exploratory Biomarkers Analysis
MAD phase: Day 1 and Day 14 at predose, 1.5 hours and 24 hours
Cohort 1: A single daily dose of 2.5mg IFB-088 in oral capsule, is administered with 250 ml of water at room temperature, in the morning around 8:00am, in one intake
Cohort 1: A single daily dose of 2.5mg placebo in oral capsule, is administered with 250 ml of water at room temperature, in the morning around 8:00am, in one intake
SAD phase: IFB-088 will be administered during 1 day, in one (2.5mg) or 2 (5.0-60.0mg) intakes separated by an interval of 12 hours
Eurofins|Optimed
Gières, 38610, France
Centre d'Investigation Clinique - Centre de Pharmacologie Clinique et d'Evaluations Thérapeutiques (CIC-CPCET)
Marseille, 13385, France
Christine Audebert, MD
APHM - Centre de Pharmacolgie Clinique et d'Evaluations Thérapeutiques
72 participants (actual enrollment reported by the registry).
First Submitted
June 20, 2018
First Posted
August 1, 2018
Study Start
Cohort 2: A single daily dose of 5.0mg IFB-088 in oral capsule, divided in two doses of 2.5mg are administered with 250 ml of water at room temperature, seperated by an interval of 12h, in the morning around 8:00am, and in the evening around 8:00pm
Cohort 2: A single daily dose of 5.0mg placebo in oral capsule, divided in two doses of 2.5mg are administered with 250 ml of water at room temperature, seperated by an interval of 12h, in the morning around 8:00am, and in the evening around 8:00pm
Cohort 3: A single daily dose of 10.0mg IFB-088 in oral capsule, divided in two doses of 5.0mg are administered with 250 ml of water at room temperature, seperated by an interval of 12h, in the morning around 8:00am, and in the evening around 8:00pm
Cohort 3: A single daily dose of 10.0mg Placebo in oral capsule, divided in two doses of 5.0mg are administered with 250 ml of water at room temperature, seperated by an interval of 12h, in the morning around 8:00am, and in the evening around 8:00pm
Cohort 4: A single daily dose of 20.0mg IFB-088 in oral capsule, divided in two doses of 10.0mg are administered with 250 ml of water at room temperature, seperated by an interval of 12h, in the morning around 8:00am, and in the evening around 8:00pm
Cohort 4: A single daily dose of 20.0mg Placebo in oral capsule, divided in two doses of 10.0mg are administered with 250 ml of water at room temperature, seperated by an interval of 12h, in the morning around 8:00am, and in the evening around 8:00pm
Cohort 5: A single daily dose of 40.0mg IFB-088 in oral capsule, divided in two doses of 20.0mg are administered with 250 ml of water at room temperature, seperated by an interval of 12h, in the morning around 8:00am, and in the evening around 8:00pm
Cohort 5: A single daily dose of 40.0mg Placebo in oral capsule, divided in two doses of 20.0mg are administered with 250 ml of water at room temperature, seperated by an interval of 12h, in the morning around 8:00am, and in the evening around 8:00pm
Cohort 6: A single daily dose of 60.0mg IFB-088 in oral capsule, divided in two doses of 30.0mg are administered with 250 ml of water at room temperature, seperated by an interval of 12h, in the morning around 8:00am, and in the evening around 8:00pm
Cohort 6: A single daily dose of 60.0mg Placebo in oral capsule, divided in two doses of 30.0mg are administered with 250 ml of water at room temperature, seperated by an interval of 12h, in the morning around 8:00am, and in the evening around 8:00pm
Cohort 7: subject taking 15.0mg of IFB-088 in oral capsule divided into 2 doses of 7.5mg administered with 250ml of water at room temperature, seperated by an interval of 12h, in the morning around 8:00am, an in the evening around 8:00pm, for 14 days.
Cohort 7: subject taking 15.0mg of placebo in oral capsule divided into 2 doses of 7.5mg administered with 250ml of water at room temperature, seperated by an interval of 12h, in the morning around 8:00am, an in the evening around 8:00pm, for 14 days.
Cohort 8: subject taking 30.0mg of IFB-088 in oral capsule divided into 2 doses of 15.0mg administered with 250ml of water at room temperature, seperated by an interval of 12h, in the morning around 8:00am, an in the evening around 8:00pm, for 14 days.
Cohort 8: subject taking 30.0mg of Placebo in oral capsule divided into 2 doses of 15.0mg administered with 250ml of water at room temperature, seperated by an interval of 12h, in the morning around 8:00am, an in the evening around 8:00pm, for 14 days.
Cohort 9: subject taking 50.0mg of IFB-088 in oral capsule divided into 2 doses of 25.0mg administered with 250ml of water at room temperature, seperated by an interval of 12h, in the morning around 8:00am, an in the evening around 8:00pm, for 14 days.
Cohort 9: subject taking 50.0mg of Placebo in oral capsule divided into 2 doses of 25.0mg administered with 250ml of water at room temperature, seperated by an interval of 12h, in the morning around 8:00am, an in the evening around 8:00pm, for 14 days.
SAD phase: placebo (microcrystalline cellulosis) will be administered during 1 day, in one (2.5mg) or 2 (5.0-60.0mg) intakes separated by an interval of 12 hours
MAD phase: multiple doses of IFB-088 (15.0-50.0mg) will be administered daily during 14 days, in two intakes, separated by an interval of 12 hours.
MAD phase: multiple doses of placebo (microcrystalline cellulosis, 15.0-50.0mg) will be administered daily during 14 days, in two intakes, separated by an interval of 12 hours.
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June 21, 2018
Actual (reported)Primary Completion
June 21, 2019
Actual (reported)Study Completion
December 16, 2019
Actual (reported)Last Updated
January 26, 2022
Results First Posted
January 26, 2022
Record last verified: 2021-11
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