RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED DOSE ESCALATION STUDY TO EVALUATE THE SAFETY AND PHARMACOKINETICS OF SINGLE AND MULTIPLE DOSES OF 2-IMINOBIOTINE (2-IB) IN HEALTHY MALE SUBJECTS

Completed

• Conditions: Oxygen deprivation; 10016849

• Registration Number: NL-OMON35086
• Lead Sponsor: europhyxia B.V.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 6 May 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 18

Inclusion Criteria

Healthy male, 18-55 years of age, BMI 18 and 28 kg/m2, total body weight does not exceed 90 kg, a good venous accessibility for both arms, non or moderate smoker

Exclusion Criteria

Suffering from: hepatitis B, cancer or HIV/AIDS. In case of participation in another drug study within 60 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>Pharmacokinetics:<br /><br>plasma concentrations of 2-IB; PK parameters in plasma and urine: Cmax, tmax,<br /><br>kel, t1/2, AUC0-t, AUC0 inf, %AUC, AUC0-4, CL, Vz, MRT, Ae0-t<br /><br><br /><br>Safety:<br /><br>AEs, vital signs, 12-lead ECG, clinical laboratory, infusion site inspection<br /><br>and physical examination</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>na</p><br>