Safety, Tolerability,Pharmacokinetics and Pharmacodynamics of ODM-106 in Healthy Volunteers

NCT02393950 | Completed Phase 1 Results DMC

• 2 other identifiers: 31170012014-001317-33
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief Summary

The study is a dose escalation study with 8 planned dose levels. The study is a 4-period crossover design where each healthy volunteer will be randomised to receive three dose levels of ODM-106 (single doses) and one dose of placebo. The study will look at the pharmacokinetics (how the body handles the drug) and pharmacodynamics (how the drug affects the body) of ODM-106.

Conditions

Healthy Volunteer Study

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Adverse Events as a Measure of Safety. Number of Participants With Adverse Events Related to Tolerability.

  Clinically relevant changes from baseline in safety laboratory assessments (haematology, clinical chemistry, urinalysis), vital signs (pulse and heart rate), 12 lead electrocardiograms, Holter electrocardiograms, telemetry, physical examination.

  From screening up to 16 weeks

Secondary Outcomes (9)

• Peak Plasma Concentration (cMax) of ODM-106

  Pre-dose and 15, 30 and 45 min, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24, 48, 72 and 96 hours post dose at each dose level.

• Area Under the Plasma Concentration Versus Time Curve (AUC) of ODM-106

  Pre-dose and 15, 30 and 45 min, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24, 48, 72 and 96 hours post dose at each dose level. Urine sampling, pre-dose and for 24 hours post dose at each dose level

• Time to Peak Plasma Concentration (Tmax) of ODM-106

  Pre-dose and 15, 30 and 45 min, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24, 48, 72 and 96 hours post dose at each dose level

• Elimination Half-life of ODM-106

  Pre-dose and 15, 30 and 45 min, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24, 48, 72 and 96 hours post dose at each dose level.

• Metabolite Screening in Plasma and Urine

  Plasma samples at pre-dose and 15, 30 and 45 min, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24, 48, 72 and 96 hours post dose at each dose level. Urine samples, pre-dose and for 24 hours post dose at each dose level

Study Arms (2)

Drug: ODM-106

EXPERIMENTAL

Oral capsules dosage 2-800mg once daily for one day

Drug: ODM-106

Drug: Placebo

PLACEBO COMPARATOR

Oral capsules given once daily for one day

Drug: Placebo

Interventions

ODM-106 DRUG

Single oral escalating doses of ODM-106 will be administered. Each subject will participate in 4 study periods and will therefore receive 3 single doses of ODM-106 and one single dose of placebo.

Drug: ODM-106

Placebo DRUG

Single oral escalating doses of ODM-106 will be administered. Each subject will participate in 4 study periods and will therefore receive 3 single doses of ODM-106 and one single dose of placebo.

Drug: Placebo

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Written informed consent obtained.
• Participants must be able to speak, read and understand German.
• Good general health ascertained by detailed medical history and physical examinations.
• Males 18-45 years (inclusive).
• Body mass index (BMI) 18-30 kg/m2 inclusive
• Weight 55-95 kg (inclusive).
• Participants with female partners of child-bearing potential must adhere to a proper form of contraception from first study treatment administration until 3 months after the end-of-study visit.

You may not qualify if:

• A predictable poor compliance or inability to understand and comply with protocol requirements, instructions and protocol-stated restrictions or communicate well with the investigator.
• Vulnerable subjects.
• Veins unsuitable for repeated venipuncture.
• Evidence of clinically relevant cardiovascular, renal, hepatic, haematological, gastro-intestinal, pulmonary, metabolic-endocrine, neurological, urogenital or psychiatric disease as judged by the investigator. The participants should be healthy subjects.
• Subjects with a medical history of relevant psychiatric disorders or evidence of significant neuropsychiatric disease
• Any condition requiring regular concomitant medication including herbal products or likely to need any concomitant medication during the study.
• Definite or suspected personal history of hypersensitivity to drugs or excipients.
• Intake of any medication that could affect the outcome of the study, as judged by the investigator, within 2 weeks before first study treatment administration (2 months for enzyme inducing drugs like rifampicin or carbamazepin), or less than 5 times the half-life of the medication.
• A history of alcoholism or excess alcohol intake (including regular consumption of more than 21 units of alcohol per week) .
• Use of nicotine-containing products within 6 months of admission and inability to refrain from using nicotine-containing products during the study.
• History of drug abuse or positive drug screen for amphetamine, barbiturates, benzodiazepines, cannabinoids, cocaine, opiates, methamphetamine or methadone.
• Propensity to get headache when refraining from caffeine-containing beverages.
• Blood donation or loss of clinically relevant amount of blood within 2 months before the screening visit.
• Abnormal 12-lead ECG finding of clinical relevance at the screening visit
• Heart rate (HR) \< 50 bpm or \> 90 bpm after 10 min in rest (supine) at the screening visit

Sponsors & Collaborators

• Orion Corporation, Orion Pharma: lead

Study Sites (1)

Parexel International GmbH

Berlin, Germany

Location

Results Point of Contact

• Title: Clinical Trials Information Desk
• Organization: Orion Corporation

clinicaltrials@orionpharma.com

+358104261

Study Officials

• Rainard Fuhr, MD

  Parexel International GmbH, Berlin, Germany

  PRINCIPAL INVESTIGATOR

• John Whiteside

  Orion Corporation, Orion Pharma

  STUDY DIRECTOR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 6, 2015
• First Posted: March 20, 2015
• Study Start: March 1, 2015
• Primary Completion: October 1, 2015
• Study Completion: March 1, 2016
• Last Updated: December 23, 2016
• Results First Posted: December 23, 2016

Record last verified: 2016-03

Locations

DE (1)