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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

101 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-05-31

Study Completion Date

2014-12-31

Brief Summary

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

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Detailed Description

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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.

Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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ODM-104

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

Group Type EXPERIMENTAL

ODM-104

Intervention Type DRUG

ODM-104

Placebo

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

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo

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

Group Type ACTIVE_COMPARATOR

Entacapone

Intervention Type DRUG

entacapone + levodopa/carbidopa

levodopa/carbidopa

Intervention Type DRUG

entacapone + levodopa/carbidopa

Interventions

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ODM-104

Intervention Type DRUG

Placebo

Intervention Type DRUG

Entacapone

entacapone + levodopa/carbidopa

Intervention Type DRUG

levodopa/carbidopa

entacapone + levodopa/carbidopa

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes