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

Safety, Tolerability, Pharmacokinetics and Pharmacodynamic Effects of Single and Repeated Escalating Doses of ODM-104: a Randomised, Double-blind, Placebo- and Entacapone-controlled Single Centre First-in-man Study in Healthy Volunteers.

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01840423

Acronym

NOCIFIM

Enrollment

101

Registered

2013-04-25

Start date

2013-05-31

Completion date

2014-12-31

Last updated

2015-04-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

Keywords

First in man study, Volunteer study

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.

Interventions

DRUGODM-104

ODM-104

DRUGPlacebo

Placebo

DRUGEntacapone

entacapone + levodopa/carbidopa

DRUGlevodopa/carbidopa

entacapone + levodopa/carbidopa

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

MALE

Age

18 Years to 45 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026