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

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 - First-in-human 2-IB dose escalation study

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON35086

Enrollment

Registered

2009-11-18

Start date

2009-12-15

Completion date

Unknown

Last updated

2024-05-06

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

Conditions

Oxygen deprivation

Interventions

Study Medication Active substance : 2-IB Activity : unknown Indication : unknown Strength : for Groups 1a, 1b and 1c: 1.0 mg/mL in pH 4 citrate buffer for Group 2: 4.0 mg/mL in pH 4 citrate buffe

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

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

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.

Design outcomes

Primary

Measure	Time frame
Pharmacokinetics: plasma concentrations of 2-IB; PK parameters in plasma and urine: Cmax, tmax, kel, t1/2, AUC0-t, AUC0 inf, %AUC, AUC0-4, CL, Vz, MRT, Ae0-t Safety: AEs, vital signs, 12-lead ECG, clinical laboratory, infusion site inspection and physical examination	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)