This is a Single Ascending Dose Tolerance Study

A Double-Blind, Randomized, Placebo Controlled, Single Ascending Dose Study to Assess the Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Profiles of SLV354 After Oral Dose Administration in Healthy Adult Male Subjects

Status

Terminated

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01133574

Enrollment

Registered

2010-05-31

Start date

2010-02-28

Completion date

2010-07-31

Last updated

2011-08-29

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

Conditions

Cognition Disorders

Keywords

Healthy volunteers, SLV354, Phase I, SRDT

Brief summary

This is a single rising dose tolerance (Part A) followed by a functional magnetic resonance imaging (Part B)

Detailed description

The Part A of this study is a parallel design followed in a second part by a cross-over design

Interventions

DRUGSLV354 capsules

20 mg

DRUGPlacebo capsules

placebo

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

MALE

Age

18 Years to 55 Years

Healthy volunteers

Yes

Inclusion criteria

* BMI 18.0 to 28.0 kg/m2, * systolic blood pressure 90-140 mmHg, * diastolic blood pressure 50-90 mmHg, * heart rate 50 100 beats/min (all inclusive), * clinically normal safety ECG and laboratory results

Exclusion criteria

* relevant disease, * treated with SLV354 before

Design outcomes

Primary

Measure	Time frame
Safety and tolerability assessments including adverse events, clinical laboratory tests, ECG and vital signs (Part A)	1 week after each dose level
Safety and tolerability assessments including adverse events, clinical laboratory tests, ECG and vital signs (Part B)	2 weeks after each dose

Secondary

Measure	Time frame
Pharmacokinetic parameters (AUC and Cmax) after single ascending oral dosing of max. 8 doses of SLV354 ranging from 20 to 1250 mg (Part A)	1 week after each dose level
Pharmacodynamic variables (EEG, Cognitive tests, Questionnaires, plasma hormones ACTH / cortisol / TSH / T3 / T4) (Part A)	1 week after each dose level
Pharmacokinetic parameters (AUC and Cmax) after single oral dosing of 2-4 doses of SLV354 chosen (Part B)	2 weeks after each dose
Pharmacodynamic variables : Cognitive tests, Questionnaires, fMRI) (Part B)	2 weeks after each dose

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026