First in Man Study With SLV342

A Double-blind, Randomized, Placebo-controlled Study to Investigate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of SLV342 in Young Healthy Male Subjects

Status

Terminated

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00985478

Enrollment

Registered

2009-09-28

Start date

2010-01-31

Completion date

2010-06-30

Last updated

2011-08-25

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

Conditions

Pharmacokinetics

Keywords

First in Man, SLV342, Atherosclerosis

Brief summary

First in man study with single and multiple rising doses with SLV342

Interventions

DRUGSLV342

25 mg once daily - Maximal Tolerated Dose

DRUGplacebo

matching 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

* Healthy

Exclusion criteria

* Not healthy

Design outcomes

Primary

Measure	Time frame
Safety and tolerability parameters: adverse event, vital signs, 12-Lead ECG, continuous lead II ECG monitoring, laboratory safety variables and physical examination	28 Days

Secondary

Measure	Time frame
Pharmacokinetic parameters: Plasma: Cmax, tmax, AUC, t½, λz, CL/F, and Vz/F. Urine: Aeurine, fe, and CLR	28 days
Pharmacodynamic parameters: biochemistry and 24 h Holter monitoring	28 days
Midazolam PK parameters	24 hours

Countries

United Kingdom

Outcome results

None listed

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