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

Orion Pharma

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: Entacapone; Drug: ODM-104; Drug: Placebo; Drug: levodopa/carbidopa

Study type: Interventional

Funder types: Industry

Identifiers

NCT01840423

3112001

Details and patient eligibility

About

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

Full 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.

Enrollment: 101 patients

Sex: Male

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

101 participants in 3 patient groups, including a placebo group

ODM-104

Experimental group

Description:

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

Treatment:

Drug: ODM-104

Placebo

Placebo Comparator group

Description:

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

Treatment:

Drug: Placebo

entacapone + levodopa/carbidopa

Active Comparator group

Description:

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

Treatment:

Drug: levodopa/carbidopa

Drug: Entacapone