A study evaluating the pharmacokinetics, safety and tolerability of OP2113 administered intravenously in healthy volunteers and a marketed formulation administered orally

Completed

• Conditions: inhibition of ROS production; reduction/prevention of myocardial necrosis; 10028593

• Registration Number: NL-OMON48072
• Lead Sponsor: OP2 Drugs

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 2021-08-27
• Last Update Posted: 15 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 12

Inclusion Criteria

Healthy male and female subjects aged between 18 and 65 years (inclusive) with
a body mass index (BMI) of *18.0 kg/m2 and * 30.0 kg/m2 (inclusive) at
Screening.
Further inclusion criteria can be found in the protocol section 8.4.1

Exclusion Criteria

Relevant prior or ongoing medical condition that, in the Investigator*s
opinion, could adversely affect the safety of the subject.
History of clinically-significant hypersensitivity to any of the study drugs,
excipients or materials used to administer the study medication.
Further exclusion criteria can be found in the protocol section 8.4.2

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Pharmacokinetic endpoints of ATT (free) and ATX (free and total) include Cmax,<br /><br>Tmax, AUC0-last, AUC0-inf, AUC0-24,), t1/2, *Z, AR (only for PK samples<br /><br>collected during TID oral dosing). Pharmacokinetic endpoints of ATT (free) only<br /><br>are: CL/F (oral formulation) or CL (i.v. formulation), Vz/F (oral formulation)<br /><br>or Vz (i.v. formulation, C0 (i.v. formulation).</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Safety parameters include adverse events (AEs), vital signs, electrocardiogram<br /><br>(ECG), clinical laboratory assessments and local tolerability (only for i.v.<br /><br>dosing). </p><br>