Safety and Tolerability Study With Single Ascending Doses... | NCT00693316

Studies
Safety and Tolerability Study With Single Ascending Doses of ORM-12741

NCT00693316

Sponsor

Orion Corporation, Orion Pharma

Status

Completed

Last Update Posted

Feb 11, 2010Estimated

Enrollment

120Actual

Phase

Phase 1

Conditions

Healthy

Interventions

ORM-12741

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2010

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 2008

Primary Completion Date

Oct 2009Actual

Completion Date

Oct 2009Actual

First Submitted Date

May 30, 2008

First Submission Date that Met QC Criteria

Jun 6, 2008

First Posted Date

Jun 9, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 10, 2010

Last Update Posted Date

Feb 11, 2010Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

120Actual

Label	Type	Description	Intervention Names
ORM-12741	Experimental		Drug: ORM-12741
Placebo	Placebo Comparator		Drug: ORM-12741

Name	Type	Description	Arm Group Labels	Other Names
ORM-12741	Drug	Alternating panel single dose escalation.	ORM-12741 Placebo

Measure	Description	Time Frame
Safety measures, i.e. assessing adverse events, vital signs, ECG, safety laboratory values		About 8 weeks

Measure	Description	Time Frame
Pharmacokinetics		5 days after each dose

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Good general health ascertained by detailed medical history and physical examinations
Males between 18 and 45 years
Body mass index (BMI) between 18-30 kg/m2
Weight 55-90 kg

Exclusion Criteria:

Evidence of clinically significant cardiovascular, renal, hepatic, haematological, gastro-intestinal, pulmonary, metabolic-endocrine, neurological, urogenital or psychiatric disease
Any condition requiring regular concomitant treatment including herbal products or likely to need any concomitant treatment during the study
Susceptibility to severe allergic reactions
Regular consumption of more than 14 units of alcohol per week
Current use of nicotine-containing products more than 5 cigarettes or equivalent/day
Inability to refrain from using nicotine-containing products during the stay in the study centre
Inability to refrain from consuming caffeine-containing beverages during the stay in the study centre
Blood donation or loss of significant amount of blood within 3 months prior to the screening visit
Abnormal finding in ECG, vital signs, laboratory tests or physical examination
Participation in a drug study within 3 months prior to the start of this study

Accepts Healthy Volunteers

Yes

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

45 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided