NCT00885989

Brief Summary

This study will investigate the safety and tolerability of the first IV dosing of SLV338 in healthy volunteers.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
42

participants targeted

Target at P50-P75 for phase_1 healthy

Timeline
Completed

Started May 2009

Typical duration for phase_1 healthy

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 30, 2009

Completed
3 months until next milestone

First Posted

Study publicly available on registry

April 22, 2009

Completed
9 days until next milestone

Study Start

First participant enrolled

May 1, 2009

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2009

Completed
Last Updated

January 29, 2010

Status Verified

January 1, 2010

Enrollment Period

7 months

First QC Date

January 30, 2009

Last Update Submit

January 28, 2010

Conditions

Healthy

Keywords

SLV338phase Ihealthy volunteers

Outcome Measures

Primary Outcomes (1)

  • Safety and tolerability parameters, including administration site tolerability, adverse events, clinical laboratory tests, vital signs and ECG

    7 days

Secondary Outcomes (2)

  • Pharmacokinetic parameters: AUC, Cmax, tmax, t½, λz, CL, CLR, Vz, Vss, MRT, Ae, and fe.

    48 hours

  • Pharmacodynamic parameters: Plasma levels of ANP, cGMP, BNP, VIP, Big ET, ET-1, angiotensin II and aldosteron. Urinary volume and urine levels of cGMP, sodium, potassium, chloride, uric acid and creatinine, and creatinine clearance.

    48 hours

Study Arms (2)

1

EXPERIMENTAL
Drug: SLV338

2

PLACEBO COMPARATOR
Drug: Placebo

Interventions

SLV338DRUG

5 - 1000 mg IV

1
PlaceboDRUG

Placebo

2

Eligibility Criteria

Age18 Years - 55 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • healthy

You may not qualify if:

  • not healthy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Site 1

London, United Kingdom

Location

Study Officials

  • Global Clinical Director Solvay

    Solvay Pharmaceuticals

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

January 30, 2009

First Posted

April 22, 2009

Study Start

May 1, 2009

Primary Completion

December 1, 2009

Study Completion

December 1, 2009

Last Updated

January 29, 2010

Record last verified: 2010-01

Locations

GB(1)