First in Man Study With SLV341

A Double-blind, Randomized, Placebo-controlled Study to Investigate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of SLV341 in Young Healthy Male Subjects

Status

Terminated

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00887445

Enrollment

Registered

2009-04-24

Start date

2008-07-31

Completion date

2009-05-31

Last updated

2010-04-28

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

Conditions

Diabetes

Keywords

First in Man, SLV341, diabetes

Brief summary

First in man study with single and multiple rising doses with SLV341

Interventions

DRUGSLV341

5 - 1000mg once daily

DRUGplacebo

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

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.	7 days

Secondary

Measure	Time frame
Pharmacokinetic parameters: Plasma: Cmax, tmax, AUC, t½, λz, CL/F, and Vz/F. Urine: Aeurine, fe, and CLR	1 - 28 days
Pharmacodynamic parameters: biochemistry and 24 h Holter monitoring.	28 days
Interaction with Midazolam	24 hours

Countries

United Kingdom

Outcome results

None listed

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