AZD8683 Single Ascending Dose Study

NCT00979849 | Completed Phase 1

• 1 other identifier: D1883C00001
• Study Type: interventional
• Target: 130
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of the study is to assess the safety, tolerability, pharmacokinetics and pharmacodynamics of AZD8683 following single ascending dose administrations in healthy male subjects.

Conditions

Healthy Volunteers

Keywords

safety; tolerability; healthy; inhalation

Outcome Measures

Primary Outcomes (1)

• Safety variables (ECG, adverse events, blood pressure, pulse, body temp, safety lab)

  Frequent sampling occasions during study days, before and up to 48 h after dosing, and at a follow-up visit 7-13 days after dosing.

Secondary Outcomes (4)

• Pharmacokinetics: Maximum plasma concentration (Cmax), time to Cmax (tmax), terminal rate constant (λz), terminal half-life (t½λz)

  Frequent sampling occasions during study days, before and up to 48 h after dosing.

• Pharmacokinetics: Area under the plasma concentration-time curve from zero to the time of the last measurable concentration (AUC(0-t)) and from zero to infinity (AUC), apparent plasma clearance (CL/F)

  Frequent sampling occasions during study days, before and up to 48 h after dosing.

• Pharmacokinetics: Apparent volume of distribution during terminal phase (Vz/F), mean residence time (MRT), amount of drug excreted unchanged (Ae; % dose), and renal clearance (CLR).

  Frequent sampling occasions during study days, before and up to 48 h after dosing.

• Pharmacodynamics: Lung function by spirometry (forced expiratory volume in the first second [FEV1] and forced vital capacity [FVC]), blood pressure, pulse, QTc, and heart rate.

  Frequent sampling occasions during study days, before and up to 48 h after dosing.

Study Arms (2)

A

EXPERIMENTAL

AZD8683

Drug: AZD8683

B

PLACEBO COMPARATOR

Placebo

Drug: Placebo

Interventions

AZD8683 DRUG

Solution for nebulisation, inhaled. Each subject will receive a single-dose of AZD8683 or placebo. Starting dose 1 ug (lung deposited dose) with up to 8 dose escalation not exceeding AstraZeneca pre-defined exposure limits.

A

Placebo DRUG

Solution for nebulisation, inhaled

B

Eligibility Criteria

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

You may qualify if:

• Provision of signed, written and dated informed consent prior to any study specific procedures
• Have a body mass index (BMI) between 19 and 30 kg/m2 and weigh at least 50 kg and no more than 100 kg
• Be non-smoker or ex-smoker who has stopped smoking (or using other nicotine products) for \>6 months prior to study start

You may not qualify if:

• Any clinically significant disease or disorder
• Any clinically significant abnormalities at screening examinations
• Use any prescribed or non-prescribed medication

Sponsors & Collaborators

• AstraZeneca: lead

Study Sites (1)

Research Site

Philadelphia, Pennsylvania, United States

Location

MeSH Terms

Conditions

Respiratory Aspiration

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Gurdrun Schwabe

  AstraZeneca R&D Lund

  STUDY DIRECTOR

• Sylvan Hurewitz

  AstraZeneca CPU, Philadelphia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: September 17, 2009
• First Posted: September 18, 2009
• Study Start: October 1, 2009
• Primary Completion: January 1, 2010
• Study Completion: January 1, 2010
• Last Updated: March 2, 2010

Record last verified: 2010-03

Locations

US (1)