NOCOS: Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of ODM-103 in Healthy Volunteers

Sponsor

Orion Corporation, Orion Pharma (Industry)

Overall Status

Completed

CT.gov ID

NCT01688089

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

2.8

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study is to evaluate the safety and tolerability of escalating doses of ODM-103 when given to healthy male volunteers.

Condition or Disease	Intervention/Treatment	Phase
Healthy	Drug: ODM103 Drug: Placebo Drug: Entacapone Drug: Levodopa/carbidopa	Phase 1

Detailed Description

The study is divided into two parts. Part one is a crossover study where healthy volunteers will receive two doses of ODM-103 and one dose of placebo. Part II of the study is a multiple ascending dose parallel group study where healthy volunteers will receive ODM-103 three times daily for seven days. Healthy volunteers taking part in Part II of the study will also receive levo/carbidopa and entacapone four times daily on day 1 and levo/carbidopa in addition to ODM-103 on day 9. The study will also look at the pharmacokinetic(how the body handles the drug) and pharmacodynamics (how the drug affects the body) of ODM-103.

Study Design

Study Type:

Interventional

Actual Enrollment :

67 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

Double (Participant, Investigator)

Official Title:

Safety, Tolerability, Pharmacokinetics and Pharmacodynamic Effects of Single and Repeated Escalating Doses of ODM-103: a Randomised, Double-blind, Placebo- and Entacapone-controlled Single Centre First-in-man Study in Healthy Volunteers.

Study Start Date :

Sep 1, 2012

Actual Primary Completion Date :

Sep 1, 2014

Actual Study Completion Date :

Sep 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
Experimental: ODM-103 Oral capsules dosage 10-800mg once daily for one day or three times daily for 7 days	Drug: ODM103
Placebo Comparator: Placebo Oral capsules given once daily for one day or three times daily for 7 days	Drug: Placebo
Active Comparator: entacapone + levodopa/carbidopa entacapone: oral tablet 200mg given four times daily for one day; levodopa/carbidopa: oral tablet 100/25mg given four times daily for one day	Drug: Entacapone Drug: Levodopa/carbidopa

Arm

Intervention/Treatment

Experimental: ODM-103

Oral capsules dosage 10-800mg once daily for one day or three times daily for 7 days

Drug: ODM103

Placebo Comparator: Placebo

Oral capsules given once daily for one day or three times daily for 7 days

Drug: Placebo

Active Comparator: entacapone + levodopa/carbidopa

entacapone: oral tablet 200mg given four times daily for one day; levodopa/carbidopa: oral tablet 100/25mg given four times daily for one day

Drug: Entacapone

Drug: Levodopa/carbidopa

Outcome Measures

Primary Outcome Measures

Erythrocyte Catechol-O-methyltransferase (COMT) inhibition. [0, 0.16, 0.33, 0.5, 0.75,1.0,1.5, 2, 3, 4, 6, 10, 16, 24h post dose]
Maximal COMT inhibition and area under the COMT inhibition curve (AUCC)

Secondary Outcome Measures

Area under the plasma concentration curve (AUC) [0, 0.16, 0.33, 0.5, 0.75, 1, 1.5, 2, 2, 4, 6, 10, 16, 24h post dose]
AUC under the plasma concentration curve

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 45 Years

Sexes Eligible for Study:

Male

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

Male subjects aged between 18 and 45 years
BMI 18-30 kg/m2
Weight 55-90kg
Written informed consent
Good General Health

Exclusion Criteria:

Vulnerable subjects
Veins unsuitable for repeated venipuncture
Evidence of clinically significant cardiovascular, renal, hepatic, hematological, Gi, pulmonary, metabolic-endocrine, neurological, urogenital or psychiatric disorder
History of or positive test for drug abuse
Any condition requiring regular concomitant medication
Blood donation or significant loss of blood within 3 months prior to screening
Abnormal 12 lead ECG finding of clinical relevance
Heart rate (HR) <50bpm or >90bpm after 10 minutes in a supine position
Systolic blood pressure <90mmHg or >140mmHg after 10 minutes in a supine position
Diastolic blood pressure <50mmHg or >90mmHg after 10 minutes in a supine position
Abnormal 24 hour Holter recording of clinical relevance at screening
Any abnormal laboratory value, vital signs or physical examination causing a health risk to the volunteer

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Parexel International GmbH	Berlin		Germany

Sponsors and Collaborators

Orion Corporation, Orion Pharma

Investigators

Principal Investigator: Rainard Fuhr, MD, Parexel

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Orion Corporation, Orion Pharma

ClinicalTrials.gov Identifier:

NCT01688089

Other Study ID Numbers:

3109001

First Posted:

Sep 19, 2012

Last Update Posted:

Sep 19, 2014

Last Verified:

Sep 1, 2014

Keywords provided by Orion Corporation, Orion Pharma

volunteer

study

Additional relevant MeSH terms:

Levodopa

Carbidopa

Entacapone

Study Results

No Results Posted as of Sep 19, 2014