Pharmacokinetic Study of Single Doses of ORM-12741

NCT02319057 | Completed Phase 1 DMC

• 2 other identifiers: 30980112014-000193-19
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to evaluate ORM-12741 concentrations in the blood after different study drug formulations

Conditions

Healthy

Keywords

Healthy volunteer study

Outcome Measures

Primary Outcomes (1)

• Pharmacokinetics

  Explore the PK profile (e.g. Cmax, tmax, AUC, t1/2) and determine protein binding

  Blood samples collected frequently on day 1 and once or twice a day for 4 days

Secondary Outcomes (1)

• Safety measures, i.e. assessing adverse events, vital signs, ECG, safety laboratory values

  24 hours per period

Study Arms (6)

Panel 1

EXPERIMENTAL

Adaptive design: Each subject will receive 1-4 single doses of ORM-12741 including various dose levels of ORM-12741 MR A, ORM-12741 MR B, ORM-12741 IR or combination of these

Drug: ORM-12741 MR A; Drug: ORM-12741 IR; Drug: ORM-12741 MR B

Panel 2

EXPERIMENTAL

Adaptive design: Each subject will receive 1-4 single doses of ORM-12741 including various dose levels of ORM-12741 MR A, ORM-12741 MR B, ORM-12741 IR or combination of these

Drug: ORM-12741 MR A; Drug: ORM-12741 IR; Drug: ORM-12741 MR B

Panel 3

EXPERIMENTAL

Adaptive design: Each subject will receive 1-4 single doses of ORM-12741 including various dose levels of ORM-12741 MR A, ORM-12741 MR B, ORM-12741 IR or combination of these

Drug: ORM-12741 MR A; Drug: ORM-12741 IR; Drug: ORM-12741 MR B

Panel 4

EXPERIMENTAL

Adaptive design: Each subject will receive 1-4 single doses of ORM-12741 including various dose levels of ORM-12741 MR A, ORM-12741 MR B, ORM-12741 IR or combination of these

Drug: ORM-12741 MR A; Drug: ORM-12741 IR; Drug: ORM-12741 MR B

Panel 5

EXPERIMENTAL

Adaptive design: Each subject will receive 1-4 single doses of ORM-12741 including various dose levels of ORM-12741 MR A, ORM-12741 MR B, ORM-12741 IR or combination of these

Drug: ORM-12741 MR A; Drug: ORM-12741 IR; Drug: ORM-12741 MR B

Panel 6

EXPERIMENTAL

Adaptive design: Each subject will receive 1-4 single doses of ORM-12741 including various dose levels of ORM-12741 MR A, ORM-12741 MR B, ORM-12741 IR or combination of these

Drug: ORM-12741 MR A; Drug: ORM-12741 IR; Drug: ORM-12741 MR B

Interventions

ORM-12741 MR A DRUG

Modified release formulation of ORM-12741

Panel 1; Panel 2; Panel 3; Panel 4; Panel 5; Panel 6

ORM-12741 IR DRUG

Immediate release formulation of ORM-12741

Panel 1; Panel 2; Panel 3; Panel 4; Panel 5; Panel 6

ORM-12741 MR B DRUG

Modified release formulation of ORM-12741

Panel 1; Panel 2; Panel 3; Panel 4; Panel 5; Panel 6

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• 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 examination.
• Females and males between 18 and 65 years of age (inclusive).
• Body mass index (BMI) between 18-30 kg/m2 (inclusive, BMI = weight/height2).
• Weight of 50-100 kg (inclusive).
• Regular intestinal transit (no recent history of recurrent constipation, diarrhoea, or other intestinal problems).

You may not qualify if:

• Predicted poor compliance or inability to communicate well with the investigator or the study centre personnel.
• Veins unsuitable for repeated venipuncture or cannulation.
• Evidence of clinically significant cardiovascular, renal, hepatic, haematological, gastrointestinal, pulmonary, metabolic-endocrine, neurological, urogenital or psychiatric disease as judged by the investigator.
• Any condition requiring regular concomitant treatment (including vitamins and herbal products) or likely to need any concomitant treatment during the study. Hormonal contraception and hormone replacement therapy are allowed.
• Susceptibility to severe allergic reactions.
• Intake of any medication that could affect the outcome of the study, within 2 weeks prior to the first study treatment administration or less than 5 times the half-life of the medication. Possible enzyme inducing drugs will be discussed case-by-case with the sponsor.
• Regular consumption of more than 21 units of alcohol per week for males and 16 units per week for females (1 unit = 4 cl spirits, about 13 g of alcohol).
• Current use of nicotine-containing products more than 5 cigarettes or equivalent/day.
• Inability to refrain from using nicotine-containing products during the stay at the study centre.
• Inability to refrain from consuming caffeine-containing beverages during the stay at the study centre, e.g. propensity to develop headaches when refraining from caffeine-containing beverages.
• Blood donation or loss of significant amount of blood within 3 months prior to the first study treatment administration.
• Any clinically significant 12-lead electrocardiogram (ECG) abnormality after a 10-minute rest in supine position at the screening visit, as judged by the investigator. For example:
• QTc (calculated with the Bazett's formula) \> 470 msec for females and 450 msec for men.
• HR \< 45 beats/minute or \> 100 beats/minute after a 10-minute rest in supine position at the screening visit.
• At the screening visit systolic blood pressure (BP) \< 90 mmHg or \> 150 mmHg after a 10- minute rest in supine position, diastolic BP \< 50 mmHg or \> 90 mmHg after a 10-minute rest in supine position, or symptomatic orthostatic hypotension, or

Sponsors & Collaborators

• Orion Corporation, Orion Pharma: lead

Study Sites (1)

Clinical Research Services Turku, CRST

Turku, Finland

Location

Study Officials

• Mika Scheinin, MD

  Clinical Research Services Turku, CRST

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: October 6, 2014
• First Posted: December 18, 2014
• Study Start: September 1, 2014
• Primary Completion: February 1, 2015
• Study Completion: February 1, 2015
• Last Updated: May 6, 2015

Record last verified: 2015-05

Locations

FI (1)