Pharmacokinetic Study of Multiple Doses of ORM-12741 (Nebula PK 2)

NCT02303860 | Completed Phase 1 DMC

• 1 other identifier: 3098013
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to evaluate ORM-12741 concentrations in blood at steady state.

Conditions

Healthy

Keywords

Healthy volunteer study

Outcome Measures

Primary Outcomes (1)

• Cmax, Tmax, AUC, T1/2

  Pharmacokinetics

  Blood samples collected once at day 2, 4, 6, 9, 10 and 11; twice on day 8 and frequently on day 7.

Secondary Outcomes (1)

• Safety - adverse events, vital signs, ECG, safety laboratory values

  8 days per treatment period

Study Arms (2)

Panel 1

EXPERIMENTAL

Adaptive design: Each subject will receive MR A or MR B formulation of ORM-12741 or a combination of these once or twice daily for one week either combined with IR formulation or not.

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

Panel 2

EXPERIMENTAL

Adaptive design: Each subject will receive MR A or MR B formulation of ORM-12741 or a combination of these once or twice daily for one week either combined with IR formulation or not.

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

Interventions

ORM-12741 MR A DRUG

Modified release formulation of ORM-12741

Panel 1; Panel 2

ORM-12741 MR B DRUG

Modified release formulation of ORM-12741

Panel 1; Panel 2

ORM-12741 IR DRUG

Immediately release formulation of ORM-12741

Panel 1; Panel 2

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 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 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 Oy

Turku, 02520, Finland

Location

Study Officials

• Mika Scheinin, MD

  Clinical Research Services Turku - CRST Oy

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: October 21, 2014
• First Posted: December 1, 2014
• Study Start: October 1, 2014
• Primary Completion: January 1, 2015
• Study Completion: January 1, 2015
• Last Updated: May 6, 2015

Record last verified: 2015-05

Locations

FI (1)