Pharmacokinetic Study of ORM-12741 in Healthy Volunteers

NCT00818740 | Completed Phase 1

• 1 other identifier: 3098003
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to determine pharmacokinetic parameters of ORM-12741 in healthy volunteers.

Conditions

Healthy Volunteers

Outcome Measures

Primary Outcomes (1)

• Pharmacokinetic variables including: Peak concentration in plasma (Cmax), Time to peak concentration in plasma (tmax), Area under the plasma concentration-time curve (AUC)

  96 hours

Secondary Outcomes (1)

• Safety variables including blood pressure (BP), heart rate (HR), electrocardiograms (ECGs), physical examination, laboratory safety variables (haematology, chemistry, serology and urinalysis) and adverse events (AEs).

  throughout the study

Study Arms (4)

ORM-12741 i.v.

EXPERIMENTAL

Drug: ORM-12741

ORM-12741 oral solution

EXPERIMENTAL

Drug: ORM-12741

ORM-12741 oral capsule with food

EXPERIMENTAL

Drug: ORM-12741

ORM-12741 oral capsule without food

EXPERIMENTAL

Drug: ORM-12741

Interventions

ORM-12741 DRUG

i.v., oral solution and oral capsule forms. Oral capsule given with and without food.

ORM-12741 i.v.; ORM-12741 oral capsule with food; ORM-12741 oral capsule without food; ORM-12741 oral solution

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Written informed consent (IC) obtained.
• Good general health ascertained by detailed medical history and physical examinations.
• Finnish speaking males between 18 and 45 years of age (inclusive).
• Body Mass Index (BMI) between 18-30 kg/m2 (inclusive, BMI = weight/height2).
• Weight of 55-100 kg (inclusive).

You may not qualify if:

• A predictable poor compliance or inability to communicate well with the investigator.
• Veins unsuitable for repeated venipuncture.
• Evidence of clinically significant cardiovascular, renal, hepatic, haematological, gastrointestinal, pulmonary, metabolic-endocrine, neurological, urogenital or psychiatric disease as judged by the investigator.
• Any condition requiring regular concomitant medication including herbal products or likely to need any concomitant treatment during the study.
• Susceptibility to severe allergic reactions.
• Intake of any medication that could affect the outcome of the study, within 2 weeks prior to the first study treatment administration or less than 5 times a half-live of the medication. Possible enzyme inducing drugs will be discussed case-by-case with the sponsor.
• Regular consumption of more than 21 units of alcohol per week (1 unit = 4 cl spirits, about 13 g of alcohol).
• Current use of nicotine-containing products more than 5 cigarettes or equivalent/day.
• Inability to refrain from using nicotine-containing products during the stay at the study centre.
• Inability to refrain from consuming caffeine-containing beverages during the stay at the study centre e.g. propensity in getting headache when refraining from caffeine-containing beverages.
• Blood donation or loss of significant amount of blood within 2 months prior to the screening visit.
• Abnormal 12-lead ECG finding of clinical relevance after 10-minute rest in supine position at the screening visit, for example:
• QTc (calculated through the Bazett's formula) \> 450msec,
• PR \< 120 msec or \> 210 msec,
• QRS \< 70 msec or \> 120 msec.

Sponsors & Collaborators

• Orion Corporation, Orion Pharma: lead

Study Sites (1)

CRST

Turku, Finland

Location

MeSH Terms

Interventions

ORM-12741

Study Officials

• Juha Peltonen, MD

  CRST

  PRINCIPAL INVESTIGATOR

• Virpi Mononen

  Orion Corporation, Orion Pharma

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: December 22, 2008
• First Posted: January 8, 2009
• Study Start: January 1, 2009
• Primary Completion: June 1, 2009
• Study Completion: June 1, 2009
• Last Updated: October 8, 2009

Record last verified: 2009-10

Locations

FI (1)