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A First Time in Man Study to Asses the Safety and Tolerability of AZD7624 in Healthy Subjects

Primary Purpose

Chronic Obstructive Pulmonary Disease (COPD)

Status

Completed

Phase

Phase 1

Locations

United Kingdom

Study Type

Interventional

Intervention

AZD7624

Placebo to match

About this trial

This is an interventional basic science trial for Chronic Obstructive Pulmonary Disease (COPD) focused on measuring Phase 1, Healthy Volunteers, Single Ascending Dose (SAD), First Time in Man, Pharmacokinetics, Pharmacodynamics

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

Healthy male and/or female subjects aged 18 to 55 years
Able to inhale from the SPIRA nebuliser according to the provided instructions
Females must have a negative pregnancy test at screening and on admission (Day 1) to the CPU, must not be lactating and must be of non-childbearing potential.
Body mass index (BMI) between 18 and 30 kg/m2 inclusive and weighing at least 50 kg and no more than 100 kg inclusive.
FEV1 >80% of the predicted normal value.

Exclusion Criteria:

History of severe allergy/hypersensitivity or ongoing clinically important allergy/hypersensitivity, as judged by the Investigator or history of hypersensitivity to drugs with a similar chemical structure or class to AZD7624
History of any clinically important disease or disorder which, in the opinion of the Investigator, may either put the subject at risk because of participation in the study, or influence the results or the subject's ability to participate in the study
History or family history of muscle diseases
Known or suspected history of drug abuse as judged by the Investigator
Use of any prescribed or non-prescribed medication including antacids, analgesics other than paracetamol/acetaminophen, herbal remedies, vitamins (excluding routine vitamins but including megadose [intake of 20 to 600 times the recommended daily dose])

Sites / Locations

Research Site

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Group 1-5, single ascending dose AZD7624

Placebo

Arm Description

Subjects will participate in 1 of 5 groups. In each group 6 subjects will receive AZD7624 and 2 subjects will receive matching placebo.

Outcomes

Primary Outcome Measures

Safety variables (adverse events, vital signs, body temperature, ECGs, clinical laboratory safety tests and spirometry)

Secondary Outcome Measures

Pharmacokinetics of AZD7624 and assess dose proportionality of the pharmacokinetics following single ascending doses of AZD7624 by assessment of Cmax, t1/2, AUC and CL/F.

Pharmacokinetics of single doses of AZD7624 using the following urine PK parameters: Ae and CLR

Full Information

NCT ID

NCT01754844

First Posted

December 19, 2012

Last Updated

April 1, 2015

Sponsor

AstraZeneca

1. Study Identification

Unique Protocol Identification Number

NCT01754844

Brief Title

A First Time in Man Study to Asses the Safety and Tolerability of AZD7624 in Healthy Subjects

Official Title

A Double-blind Placebo-controlled, Randomised, Single Centre, First Time in Man Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single Ascending Inhaled Doses of AZD7624 in Healthy Subjects

Study Type

Interventional

2. Study Status

Record Verification Date

April 2015

Overall Recruitment Status

Completed

Study Start Date

January 2013 (undefined)

Primary Completion Date

August 2013 (Actual)

Study Completion Date

August 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

AstraZeneca

4. Oversight

5. Study Description

Brief Summary

This is a First in Human study to assess the safety and tolerability of AZD7624, following inhaled administration of single ascending doses in healthy male volunteers and female volunteers of non-child bearing potential. Pharmacokinetics (what the body does to the drug) and pharmacodynamic (what the drug does to the body) parameters will be also assessed as secondary objectives.

Detailed Description

A Double-blind Placebo-controlled, Randomised, Single centre, First Time in Man Study to evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single Ascending Inhaled Doses of AZD7624 in Healthy Subjects

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Chronic Obstructive Pulmonary Disease (COPD)

Keywords

Phase 1, Healthy Volunteers, Single Ascending Dose (SAD), First Time in Man, Pharmacokinetics, Pharmacodynamics

7. Study Design

Primary Purpose

Basic Science

Study Phase

Phase 1

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

57 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Group 1-5, single ascending dose AZD7624

Arm Type

Experimental

Arm Description

Subjects will participate in 1 of 5 groups. In each group 6 subjects will receive AZD7624 and 2 subjects will receive matching placebo.

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

Subjects will participate in 1 of 5 groups. In each group 6 subjects will receive AZD7624 and 2 subjects will receive matching placebo.

Intervention Type

Drug

Intervention Name(s)

AZD7624

Intervention Description

Single dose inhaled IMP via a nebulizer

Intervention Type

Drug

Intervention Name(s)

Placebo to match

Intervention Description

Single dose inhaled Placebo via a nebulizer

Primary Outcome Measure Information:

Title

Safety variables (adverse events, vital signs, body temperature, ECGs, clinical laboratory safety tests and spirometry)

Time Frame

up to 55 days.

Secondary Outcome Measure Information:

Title

Pharmacokinetics of AZD7624 and assess dose proportionality of the pharmacokinetics following single ascending doses of AZD7624 by assessment of Cmax, t1/2, AUC and CL/F.

Time Frame

Day 1 pre-dose, 5min, 15min, 30min, 1h, 2h, 4h, 6h, 9h,12h, 18h, 24h, 36h, 48h, 56h post dose

Title

Pharmacokinetics of single doses of AZD7624 using the following urine PK parameters: Ae and CLR

Time Frame

Day 1: during 0-6, 6-12, 12-24 and 24-48 hours post dose.

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

55 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Healthy male and/or female subjects aged 18 to 55 years Able to inhale from the SPIRA nebuliser according to the provided instructions Females must have a negative pregnancy test at screening and on admission (Day 1) to the CPU, must not be lactating and must be of non-childbearing potential. Body mass index (BMI) between 18 and 30 kg/m2 inclusive and weighing at least 50 kg and no more than 100 kg inclusive. FEV1 >80% of the predicted normal value. Exclusion Criteria: History of severe allergy/hypersensitivity or ongoing clinically important allergy/hypersensitivity, as judged by the Investigator or history of hypersensitivity to drugs with a similar chemical structure or class to AZD7624 History of any clinically important disease or disorder which, in the opinion of the Investigator, may either put the subject at risk because of participation in the study, or influence the results or the subject's ability to participate in the study History or family history of muscle diseases Known or suspected history of drug abuse as judged by the Investigator Use of any prescribed or non-prescribed medication including antacids, analgesics other than paracetamol/acetaminophen, herbal remedies, vitamins (excluding routine vitamins but including megadose [intake of 20 to 600 times the recommended daily dose])

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Sam Lindgren, MD

Organizational Affiliation

AstraZeneca Research and Development SE-431 83 Molndal Sweden

Official's Role

Study Director

First Name & Middle Initial & Last Name & Degree

Darren G Wilbraham

Organizational Affiliation

Quintiles Drug Research Unit at Guy's Hospital 6 Newcomen St London SE1 1YR

Official's Role

Principal Investigator

Facility Information:

Facility Name

Research Site

City

London

Country

United Kingdom

12. IPD Sharing Statement

Learn more about this trial

A First Time in Man Study to Asses the Safety and Tolerability of AZD7624 in Healthy Subjects

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