Primary objectives1. To evaluate the pharmacokinetic (PK) profile of the parent compound (anethole trithione, ATT) and its main metabolite (5-[4-hydroxyphenyl]-3H-1,2-dithiole-3-thione, ATX ) following administration of a range of doses of i.v.…
ID
Source
Brief title
Condition
- Myocardial disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Pharmacokinetic endpoints of ATT (free) and ATX (free and total) include Cmax,
Tmax, AUC0-last, AUC0-inf, AUC0-24,), t1/2, *Z, AR (only for PK samples
collected during TID oral dosing). Pharmacokinetic endpoints of ATT (free) only
are: CL/F (oral formulation) or CL (i.v. formulation), Vz/F (oral formulation)
or Vz (i.v. formulation, C0 (i.v. formulation).
Secondary outcome
Safety parameters include adverse events (AEs), vital signs, electrocardiogram
(ECG), clinical laboratory assessments and local tolerability (only for i.v.
dosing).
Background summary
OP2 Drugs SAS is investigating whether OP2113 can limit the damage to the heart
tissue that is caused following a standard intervention after an acute heart
attack. OP2113 will be administered directly into the blood and this study
evaluates OP2113 administered as an injection and infusion for the first time.
Study objective
Primary objectives
1. To evaluate the pharmacokinetic (PK) profile of the parent compound
(anethole trithione, ATT) and its main metabolite
(5-[4-hydroxyphenyl]-3H-1,2-dithiole-3-thione, ATX ) following administration
of a range of doses of i.v. OP2113.
2. To evaluate the PK profile of ATT and ATX following administration of an
oral formulation containing ATT (after a single dose and after multiple doses).
Secondary objective
1. To evaluate the safety and tolerability, including local tolerability, of a
range of doses of i.v. OP2113.
2. To evaluate the safety and tolerability of an oral formulation containing
ATT (single dose and multiple doses).
Study design
Single site, randomized, placebo-controlled, open-label (for Oral Dosing
Period) and single-blind (for i.v administration Periods), ascending dose,
cross-over study.
Intervention
Sulfarlem S25 tablets of 25 mg
intravenous bolus injection and 12-hour infusion of OP2113
intravenous bolus injection and 12-hour infusion of saline placebo
Study burden and risks
Since this study is being executed in healthy volunteers, there are no
anticipated benefits of the IMP. Please see the IMPD for further information.
Av. Du Haut L Universite Hopital X. Arnozan
Pessac 33600
FR
Av. Du Haut L Universite Hopital X. Arnozan
Pessac 33600
FR
Listed location countries
Age
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
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2019-000933-37-NL |
| CCMO | NL69491.056.19 |