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AZD2115 Multiple Ascending Dose Study

NCT ID: NCT01445782

Last Updated: 2012-10-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-10-31

Study Completion Date

2012-07-31

Brief Summary

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This study will investigate the safety and tolerability of AZD2115 following administration of multiple ascending doses.

Detailed Description

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A Phase I, Single Centre, Double-blind, Randomised, Placebo-controlled, Parallel-group Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Multiple Ascending Inhaled Doses of AZD2115 in Healthy Male Subjects.

Conditions

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Healthy

Keywords

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Safety tolerability healthy inhaled

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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1

AZD2115

Group Type EXPERIMENTAL

AZD2115

Intervention Type DRUG

Multiple dose, oral inhalation (nebuliser solution)

2

Placebo to AZD2115

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Multiple dose, oral inhalation (nebuliser solution)

Interventions

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AZD2115

Multiple dose, oral inhalation (nebuliser solution)

Intervention Type DRUG

Placebo

Multiple dose, oral inhalation (nebuliser solution)

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Healthy male subjects aged 18 to 45 years with suitable veins for cannulation or repeated venepuncture
* Male subjects should be willing to use barrier contraception ie, condoms and spermicide, from the day of first administration of the AZD2115 until 3 months after administration and must not donate sperm for 3 months after follow-up
* 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

* Abnormal vital signs, after 10 minutes supine rest, defined as any of the following:

* Systolic BP \>140 mmHg
* Diastolic BP \>90 mmHg
* Heart rate \<40 or \>85 bpm
* Prolonged QTcF \>450 ms or shortened QTcF \<340 ms or family history of long QT syndrome
* Serum potassium concentration of \< 3.80 mmol/L on admission (Day -1)
* History of severe allergy/hypersensitivity or ongoing allergy/hypersensitivity, as judged by the investigator or history of hypersensitivity to drugs with the same class to AZD2115 or to excipients
* History or presence of gastrointestinal, pulmonary, hepatic or renal disease or any other condition known to interfere with absorption, distribution, metabolism or excretion of drugs
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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AstraZeneca

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Research Site

London, UK, United Kingdom

Site Status

Countries

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United Kingdom

Other Identifiers

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Eudract number 2011-002402-75

Identifier Type: -

Identifier Source: secondary_id

D3060C00002

Identifier Type: -

Identifier Source: org_study_id