Evaluation of blood drug level profile, effect and safety after repeated administration of a slow release formulation of S-38844 in healthy male volunteers

Evaluation of the pharmacokinetics, pharmacodynamics and safety of repeated escalating oral doses of a slow release formulation of S 38844 in healthy male volunteers An open-label, non-randomised, two-group three-period, monocentre study

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2010-020197-42-DE

Enrollment

Registered

2010-05-27

Start date

2010-08-20

Completion date

Unknown

Last updated

2012-03-19

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

Conditions

Cardiovascular Diseases MedDRA version: 13.1 Level: LLT Classification code 10007648 Term: Cardiovascular disease, unspecified System Organ Class: 10007541 - Cardiac disorders

Interventions

Product Name: S38844 Product Code: S38844 Pharmaceutical Form: Film-coated tablet Current Sponsor code: S38844 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 20- C

Eligibility

Sex/Gender

Male

Inclusion criteria

Inclusion criteria: - Caucasian male healthy volunteers; - Age between 55 and 65 years; - Absence of diseases and medical history incompatible with the study protocol. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range 8

Exclusion criteria

Exclusion criteria: History of major medical disease, psychiatric disorder or surgery likely to interfere with the handling of the study drug; History of personal or familial Long QT Syndrome; Acute or chronic systemic disorder; History of drug hypersensitivity.

Design outcomes

Primary

Measure	Time frame
Main Objective: - to assess the PK profile of S 38844 in healthy male volunteers after repeated escalating oral administration of a slow release (SR) formulation at 20, 40, 80 and 120 mg o.d. for 5 days each, under fed conditions - to describe the pharmacokinetic/pharmacodynamic (PK/PD) relationship with respect to heart rate (HR);Secondary Objective: - to assess the pharmacodynamic - to evaluate the general safety of each dose tested;Primary end point(s): PK parameters;Timepoint(s) of evaluation of this end point: until 6 days after administration	—

Measure

Time frame

Main Objective: - to assess the PK profile of S 38844 in healthy male volunteers after repeated escalating oral administration of a slow release (SR) formulation at 20, 40, 80 and 120 mg o.d. for 5 days each, under fed conditions - to describe the pharmacokinetic/pharmacodynamic (PK/PD) relationship with respect to heart rate (HR);Secondary Objective: - to assess the pharmacodynamic - to evaluate the general safety of each dose tested;Primary end point(s): PK parameters;Timepoint(s) of evaluation of this end point: until 6 days after administration

—

Secondary

Measure	Time frame
Secondary end point(s): PD and safety;Timepoint(s) of evaluation of this end point: PD 5 days and 6 days after administration, safety until follow-up visiti	—

Countries

Germany

Contacts

Public ContactClinical Studies Department

Institut de Recherches Internationales Servier

clinicaltrials@servier.com+33155 72 43 66

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026