To Assess the Effect of Administration of 2 Formulation of AZD3241 on Blood Concentration in Healthy Volunteers

AstraZeneca

Status and phase

Completed

Phase 1

Conditions

Parkinson's Disease

Treatments

Drug: Placebo

Drug: AZD3241 ER formulation 1

Drug: AZD3241 Alternative titration scheme with formulation 1 or 2

Study type

Interventional

Funder types

Industry

Identifiers

NCT01457807

D0490C00003

Details and patient eligibility

About

To evaluate the pharmacokinetics of AZD3241 following multiple administration of 2 new, different extended release formulations of tablets of AZD3241 (300 mg), in relation to the 100 mg extended release tablet used in a previous study and potential food interaction. The safety and tolerability of AZD 3241 will also be investigated as a secondary objective. In addition to these a number of exploratory objectives will be investigated with blood sampling.

Full description

A Phase I, Single-centre, Double-blind, Randomised, Placebo-controlled, Parallel Group Study to Assess the Pharmacokinetics, Safety and Tolerability of Two Different Extended Release Formulations of Tablets of AZD3241 (300 mg) after Administration of Multiple Doses in Healthy Male and Female Volunteers

Enrollment

24 patients

Sex

All

Ages

30 to 65 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Provision of signed and dated, written informed consent prior to any study specific procedures
Healthy male or female volunteers aged 30 to 65 years, inclusive, with suitable veins for cannulation or repeated venepuncture
Female volunteers must have a negative pregnancy test at Screening and on admission to the CPU, must not be lactating and must be of non childbearing potential, confirmed at Screening
Male volunteers must be willing to use barrier contraception ie, condoms, from the first day of dose administration until 3 months after the last dose of the IP
Volunteers must have a body mass index (BMI) between 18 and 30 kg/m2 and weigh at least 50 kg and no more than 100 kg

Exclusion criteria

History of severe allergy/hypersensitivity or ongoing allergy/hypersensitivity, as judged by the Investigator or history of hypersensitivity to drugs with a similar chemical structure or class to AZD3241
Orthostatic hypotension defined as 25 mmHg decrease in systolic and/or 15 mmHg decrease in diastolic BP as measured at enrolment and/or randomisation
History of intolerance or hypersensitivity to mannitol
Prolonged QT interval corrected for heart rate using Fridericia's formula (QTcF)>450 ms or shortened QTcF<340 ms or a family history of long QT syndrome
Abnormal vital signs, after 10 minutes of rest in supine position, defined as any of the following:Systolic BP>140 mmHg., Diastolic BP>90 mmHg., Heart rate<40 or >85 beats per minute.