Dose-finding Pharmacokinetic Study in Healthy Males

NCT03055936 | Completed Phase 1 Results

• 1 other identifier: 3112005
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

Brief Summary

This is a phase I PK study in healthy males.

Conditions

Healthy Volunteers

Outcome Measures

Primary Outcomes (1)

• Levodopa Area Under the Concentration-time Curve From Time 0 to the 24 h PK Sample (AUC0-24) Time 0 to the 24 h PK Sample (AUC0-24)

  Levodopa Area Under the Concentration-time Curve From Time 0 to the 24 h PK Sample (AUC0-24)

  During 24 hours

Secondary Outcomes (2)

• Fluctuation of Levodopa Cmax/Cmin, Tau

  16 hours

• Levodopa Peak Plasma Concentration (Cmax)

  24 hours

Study Arms (16)

A1

EXPERIMENTAL

levodopa 50 mg, carbidopa 12.5 mg

Drug: Levodopa; Drug: Carbidopa

B1

EXPERIMENTAL

levodopa 50 mg, carbidopa 65 mg

Drug: Levodopa; Drug: Carbidopa

C1

EXPERIMENTAL

levodopa 50 mg, carbidopa 65 mg, ODM-104 50 mg

Drug: Levodopa; Drug: Carbidopa; Drug: ODM-104

D1

EXPERIMENTAL

levodopa 50 mg, carbidopa 65 mg, ODM-104 100 mg A4 ; B4 l; C4 ; D4 levodopa 100 mg, carbidopa 65 mg, ODM-104 100 mg

Drug: Levodopa; Drug: Carbidopa; Drug: ODM-104

A2

EXPERIMENTAL

levodopa 100 mg, carbidopa 25 mg

Drug: Levodopa; Drug: Carbidopa

B2

EXPERIMENTAL

levodopa 100 mg, carbidopa 65 mg

Drug: Levodopa; Drug: Carbidopa

C2

EXPERIMENTAL

levodopa 100 mg, carbidopa 65 mg, ODM-104 50 mg

Drug: Levodopa; Drug: Carbidopa; Drug: ODM-104

D2

EXPERIMENTAL

levodopa 100 mg, carbidopa 37,5 mg

Drug: Levodopa; Drug: Carbidopa

A3

EXPERIMENTAL

levodopa 150 mg, carbidopa 65 mg, ODM-104 100 mg

Drug: Levodopa; Drug: Carbidopa; Drug: ODM-104

B3

EXPERIMENTAL

levodopa 150 mg, carbidopa 65 mg

Drug: Levodopa; Drug: Carbidopa

C3

EXPERIMENTAL

levodopa 150 mg, carbidopa 65 mg, ODM-104 50 mg

Drug: Levodopa; Drug: Carbidopa; Drug: ODM-104

D3

EXPERIMENTAL

levodopa 150 mg, carbidopa 65 mg, ODM-104 100 mg

Drug: Levodopa; Drug: Carbidopa; Drug: ODM-104

A4

EXPERIMENTAL

levodopa IR 100 mg (Sinemet), carbidopa 25 mg

Drug: Levodopa; Drug: Carbidopa

B4

EXPERIMENTAL

levodopa 100 mg, carbidopa 65 mg

Drug: Levodopa; Drug: Carbidopa

C4

EXPERIMENTAL

levodopa 100 mg, carbidopa 25 mg, ODM-104 100 mg

Drug: Levodopa; Drug: Carbidopa; Drug: ODM-104

D4

EXPERIMENTAL

levodopa 100 mg, carbidopa 65 mg, ODM-104 100 mg

Drug: Levodopa; Drug: Carbidopa; Drug: ODM-104

Interventions

Levodopa DRUG

Levodopa 50 mg or 100 mg or 150 mg

Also known as: Sinemet

A1; A2; A3; A4; B1; B2; B3; B4; C1; C2; C3; C4; D1; D2; D3; D4

Carbidopa DRUG

Carbidopa 12.5 mg or 25 mg or 65 mg

A1; A2; A3; A4; B1; B2; B3; B4; C1; C2; C3; C4; D1; D2; D3; D4

ODM-104 DRUG

ODM-104 50 mg or 100 mg

A3; C1; C2; C3; C4; D1; D3; D4

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Written informed consent (IC) obtained.
• Good general health ascertained by detailed medical history and physical examinations.
• Males between 18-65 years of age inclusive at screening.
• Body mass index (BMI) between 19-30 kg/m2 (BMI = weight/height2) inclusive at screening.
• Weight at least 55 kg inclusive at screening.
• Regular intestinal transit (no recent history of recurrent constipation, diarrhoea, or other intestinal problems, and no history of major gastrointestinal surgery).
• Subject with a partner of childbearing potential agrees to use adequate contraception from the first dose of study treatment until 90 days after the last dose of study treatment. Adequate methods of contraception include: Hormonal contraceptives, barrier methods (condom, diaphragm, cervical cap, etc.) in combination with a spermicide, intrauterine device and sexual abstinence.
• Subject agrees to not donate sperm from the first dose of study treatment until 90 days after the last dose of study treatment.

You may not qualify if:

• Evidence of clinically significant cardiovascular, renal, hepatic, haematological, gastrointestinal, pulmonary, metabolic, endocrine, neurological or psychiatric disease or cancer (except local non-melanoma skin cancer) within the previous 2 years.
• Any condition requiring regular concomitant treatment (including vitamins and herbal products) or likely to need any concomitant treatment during the study. As an exception, paracetamol for occasional pain is allowed.
• Any clinically significant abnormal laboratory value or ECG (such as prolonged QTcF \>450 ms or QRS \>120 ms) that in the opinion of the investigator could interfere with the interpretation of study results or cause a health risk for the subject if he takes part in the study.
• Known hypersensitivity to the active substances or the excipients of the drugs.
• History of vasovagal collapses or vagal reactions with unexplained reason within the previous 2 years or a tendency for vasovagal reactions during blood sampling.
• HR \< 50 bpm or \> 90 bpm in the supine position after 5 min rest at the screening visit.
• At the screening visit:
• systolic BP \< 100 mmHg or \> 140 mmHg in the supine position after 5 min rest
• diastolic BP \< 50 mmHg or \> 90 mmHg in the supine position after 5 min rest.
• Creatinine \> 1.5 x upper limit of normal (ULN) and alanine aminotransferase or aspartate aminotransferase \>1.25 x ULN at screening.
• History of anaphylactic/anaphylactoid reactions.
• Strong tendency to motion sickness.
• Recent or current (suspected) drug abuse.
• Recent or current alcohol abuse; regular drinking of more than 21 units per week (1 unit = 4 cl spirits or equivalent).
• Current use of nicotine-containing products more than 5 cigarettes (or equivalent)/day and/or inability to refrain from the use of nicotine-containing products for 48 h before the first dose in each period until collection of the 24 h PK sample in the morning of day 8.

Sponsors & Collaborators

• Orion Corporation, Orion Pharma: lead

Study Sites (1)

Nuvisan Pharma Services

Neu-Ulm, 89231, Germany

Location

MeSH Terms

Interventions

Levodopa; carbidopa, levodopa drug combination; Carbidopa

Intervention Hierarchy (Ancestors)

Dihydroxyphenylalanine; Catecholamines; Amines; Organic Chemicals; Catechols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Phenylalanine; Amino Acids, Aromatic; Amino Acids, Cyclic; Amino Acids; Amino Acids, Peptides, and Proteins; Tyrosine; Methyldopa; Hydrazines

Results Point of Contact

• Title: Clinical Study Director
• Organization: Orion Corporation, Orion Pharma

clinicaltrials@orionpharma.com

+358104264184

Study Officials

• Denis Strugala, DR.med.

  Nuvisan GmbH

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 20, 2017
• First Posted: February 16, 2017
• Study Start: February 21, 2017
• Primary Completion: June 9, 2017
• Study Completion: June 9, 2017
• Last Updated: May 27, 2021
• Results First Posted: May 27, 2021

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)