First in Man Study With SLV341

Phase 1TerminatedNCT00887445

Solvay Pharmaceuticals87 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Diabetes

Interventions

SLV341DRUG

5 - 1000mg once daily

placeboDRUG

Eligibility

Sex: MALEMin age: 18 YearsMax age: 55 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria healthy Exclusion Criteria not healthy

Locations (1)

S341.1.001 Site #

London, United Kingdom

Outcomes

Primary Outcomes

Safety and tolerability parameters: adverse event, vital signs, 12-Lead ECG, continuous lead II ECG monitoring, laboratory safety variables and physical examination.

Time frame: 7 days

Secondary Outcomes

Pharmacokinetic parameters: Plasma: Cmax, tmax, AUC, t½, λz, CL/F, and Vz/F. Urine: Aeurine, fe, and CLR

Time frame: 1 - 28 days

Pharmacodynamic parameters: biochemistry and 24 h Holter monitoring.

Time frame: 28 days

Interaction with Midazolam

Time frame: 24 hours

Data from ClinicalTrials.gov

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