Phase 1 Completed N=8 Randomized Quadruple-blind Other

A Combined SAD and MAD Study to Investigate the Safety, Tolerability and Pharmacokinetic Profile of IFB-088

Healthy Volunteers

Source: ClinicalTrials.gov NCT03610334 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Jan 2022

Primary outcomePrimary: Number of Participants With Treatment Emergent Adverse Events Per Group — 1; 0; 1; 1 Participants

Summary

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)

Outcome Measures

Outcome	Result	p-value
PRIMARY Number of Participants With Treatment Emergent Adverse Events Per Group	1; 0; 1; 1; 2; 0	—
SECONDARY Number of Participants With Change in Concomitant Medications	0; 0; 0; 0; 0; 0	—
SECONDARY Pharmacokinetic: Maximum Observed Plasma Concentration (Cmax)	0.54; 0.45; 1.19; 1.39; 2.93; 4.26	—
SECONDARY Pharmacokinetic: Time to Reach the Maximum Concentration in Plasma (Tmax)	1.5; 1.5; 2.0; 2.0; 1.0; 2.0	—
SECONDARY Pharmacokinetic: Terminal Half-life (t1/2)	4.64; 4.61; 5.92; 6.21; 5.76; 5.17	—
SECONDARY Pharmacokinetic: Area Under Plasma Concentration-time Curve From Hour 0 to Last Sample With Measurable Plasma Concentrations (AUClast)	2.25; 3.80; 12.5; 17.4; 27.4; 51.1	—
SECONDARY Pharmacokinetic: Apparent Volume of Distribution (Vd/F)	5093; 10055; 10408; 10550; 8916; 6860	—
SECONDARY Pharmacokinetic: Apparent Total Body Clearance (CL/F)	736; 1146; 1279; 1388; 926; 826	—
SECONDARY Pharmacokinetic: Renal Clearance (CLr)	167; 75.3; 117; 106; 60.5; 76.6	—
SECONDARY Pharmacokinetic: Percent of Drug Recovered in Urine (Ae %Dose)	0.52; 0.55; 0.61; 0.44; 0.29; 0.61	—
SECONDARY Number of Participants With Clinically Significant Change in Physical Evaluation During the Study	0; 0; 0; 0; 0; 0	—
SECONDARY Number of Participants With Clinically Significant Change in Physiological Parameters During the Study	0; 0; 0; 0; 0; 0	—
SECONDARY Number of Participants With With Clinically Significant Change in Cardiovascular Functions During the Study	0; 0; 0; 0; 0; 0	—
SECONDARY Number of Participants With With Clinically Significant Change in Tympanic Body Temperature During the Study	0; 0; 0; 0; 0; 0	—
SECONDARY Number of Participants With With Clinically Significant Change in Hematology Parameters During the Study	0; 0; 0; 0; 0; 0	—
SECONDARY Number of Participants With With Clinically Significant Change in Coagulation Parameters During the Study	0; 0; 0; 0; 0; 0	—
SECONDARY Number of Participants With With Clinically Significant Change in Blood Biochemistry Parameters During the Study	0; 0; 0; 0; 0; 0	—
SECONDARY Number of Participants With Clinically Significant Change in Urinary Functions/Parameters During the Study	0; 0; 0; 0; 0; 0	—
SECONDARY Number of Participants With Clinically Significant Change in Vigilance and Mood During the Study	0; 0; 0; 0; 0; 0	—

Eligibility Criteria

Inclusion Criteria

Healthy male 18 to 40 years of age inclusive, Caucasian.
Healthy as determined by a responsible and experienced physician, based on a medical evaluation including medical history, physical examination, laboratory tests, vital signs and ECG.
AST, ALT, alkaline phosphatase and bilirubin 1.5xULN is acceptable if bilirubin is fractionated and direct bilirubin 5/day within three months of the study.
History of alcohol consumption exceeding, (on average 21 drinks/week for men) within 6 months of the first dose of study medication.
Drinking excessive amounts of tea, coffee, chocolate and/or beverage containing caffeine (> 4 cups / day).
Vital signs with a clinically significant abnormality at screening.
ECG with a clinically significant abnormality at screening.
Laboratory test values outside the clinically acceptable 'normal range' for healthy volunteers at screening.
Positive HIV, Hepatitis B or Hepatitis C at screening.
Positive urine drug test or positive breath alcohol test at screening or at admission to the clinical unit.
Any medication (including St John's Wort) within 14 days before administration, or within 5 times the elimination half-life of that drug, whichever is the longest (except paracetamol).
Treatment with an investigational drug within 30 days or 5 half-lives (whichever is longer) prior to screening.
Unable to refrain from consumption of grapefruit or grapefruit juice within 7 days prior to the first dose of study medication.
Unwillingness to abstain from sexual intercourse with pregnant or lactating women or to use a condom and spermicide and another form of contraception (e.g., IUD, birth control pills taken by female partner, diaphragm with spermicide) if engaging in sexual intercourse with a woman who could become pregnant until discharge from the study and during 90 additional days.
Subjects unlikely to co-operate in the study, and/or poor compliance anticipated by the investigator.
Subject being in the exclusion period of a previous trial.
Subject having exceeded the earnings for the last 12 months, including the indemnities for the present study.
Subject who could not be contacted in case of emergency.
Subject refusing to give written informed consent.
Subject who has received blood or plasma derivatives in the year preceding the study.
Subject who has given blood within the past 3 months or has planned to give blood or sperm within the 90 days following the study.
Subject who has forfeited their freedom by administrative or legal award, or who is under guardianship or under limited judicial protection.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03610334). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.