Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of ODM-104 in Healthy Volunteers

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: ODM-104; Drug: Placebo; Drug: Entacapone; Drug: levodopa/carbidopa

• Registration Number: NCT01840423
• Lead Sponsor: Orion Corporation, Orion Pharma

Brief Summary

The purpose of this study is to evaluate the safety and tolerability of escalating doses of ODM-104 when given to healthy male volunteers.

Detailed Description

The study is divided into two parts. Part one is a crossover study where healthy volunteers will receive two doses of ODM-104 and one dose of placebo. Part II of the study is a multiple ascending dose parallel group study where healthy volunteers will receive ODM-104 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-104 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-104.

Study Timeline

• Study First Submitted: 2013-04-23
• Study First Submitted QC: 2013-04-24
• Study First Posted: 2013-04-25
• Study Start: 2013-05
• Primary Completion: 2014-12
• Study Completion: 2014-12
• Status Verified: 2015-03
• Last Update Submitted: 2015-03-31
• Last Update Posted: 2015-04-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 101

Inclusion Criteria

• Male subjects aged between 18 and 45 years
• BMI 18-30 kg/m2
• Weight 55-95kg
• 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 2 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
ODM-104	ODM-104	Oral capsules dosage 10-800mg once daily for one day or three times daily for 7 days
Placebo	Placebo	Oral capsules given once daily for one day or three times daily for 7 days
entacapone + levodopa/carbidopa	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
entacapone + levodopa/carbidopa	Entacapone	entacapone: oral tablet 200mg given four times daily for one day; levodopa/carbidopa: oral tablet 100/25mg given four times daily for one day

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (1)

Parexel International GmbH; 🇩🇪 Berlin, Germany