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

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

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.

Study Overview

• Status: Completed
• Conditions: Chronic Obstructive Pulmonary Disease (COPD)
• Intervention / Treatment: Drug: AZD7624; Drug: Placebo to match

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

• Study Type: Interventional
• Enrollment (Actual): 57
• Phase: Phase 1

Contacts and Locations

Study Locations

• United Kingdom
  • London, United Kingdom
    • Research Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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])

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group 1-5, single ascending dose AZD7624; Subjects will participate in 1 of 5 groups. In each group 6 subjects will receive AZD7624 and 2 subjects will receive matching placebo.	Drug: AZD7624; Single dose inhaled IMP via a nebulizer
Placebo Comparator: Placebo; Subjects will participate in 1 of 5 groups. In each group 6 subjects will receive AZD7624 and 2 subjects will receive matching placebo.	Drug: Placebo to match; Single dose inhaled Placebo via a nebulizer

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Safety variables (adverse events, vital signs, body temperature, ECGs, clinical laboratory safety tests and spirometry)	up to 55 days.

Secondary Outcome Measures

Outcome Measure	Time Frame
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.	Day 1 pre-dose, 5min, 15min, 30min, 1h, 2h, 4h, 6h, 9h,12h, 18h, 24h, 36h, 48h, 56h post dose
Pharmacokinetics of single doses of AZD7624 using the following urine PK parameters: Ae and CLR	Day 1: during 0-6, 6-12, 12-24 and 24-48 hours post dose.

Collaborators and Investigators

• Sponsor: AstraZeneca
• Investigators: Study Director: Sam Lindgren, MD, AstraZeneca Research and Development SE-431 83 Molndal Sweden; Principal Investigator: Darren G Wilbraham, Quintiles Drug Research Unit at Guy's Hospital 6 Newcomen St London SE1 1YR

Study record dates

Study Major Dates

• Study Start: January 1, 2013
• Primary Completion (Actual): August 1, 2013
• Study Completion (Actual): August 1, 2013

Study Registration Dates

• First Submitted: December 19, 2012
• First Submitted That Met QC Criteria: December 20, 2012
• First Posted (Estimate): December 21, 2012

Study Record Updates

• Last Update Posted (Estimate): April 2, 2015
• Last Update Submitted That Met QC Criteria: April 1, 2015
• Last Verified: April 1, 2015

More Information

Terms related to this study

• Keywords: Pharmacokinetics; Healthy Volunteers; Phase 1; Pharmacodynamics; Single Ascending Dose (SAD); First Time in Man
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Protein Kinase Inhibitors; AZD7624
• Other Study ID Numbers: D2550C00001