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

NCT01754844 | Completed Phase 1

• 1 other identifier: D2550C00001
• Study Type: interventional
• Target: 57
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Obstructive Pulmonary Disease (COPD)

Keywords

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

Outcome Measures

Primary Outcomes (1)

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

  up to 55 days.

Secondary Outcomes (2)

• 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.

Study Arms (2)

Group 1-5, single ascending dose AZD7624

EXPERIMENTAL

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

Placebo

PLACEBO COMPARATOR

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

Interventions

AZD7624 DRUG

Single dose inhaled IMP via a nebulizer

Group 1-5, single ascending dose AZD7624

Placebo to match DRUG

Single dose inhaled Placebo via a nebulizer

Placebo

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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 \[intake of 20 to 600 times the recommended daily dose\])

Sponsors & Collaborators

• AstraZeneca: lead

Study Sites (1)

Research Site

London, United Kingdom

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

AZD7624

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Sam Lindgren, MD

  AstraZeneca Research and Development SE-431 83 Molndal Sweden

  STUDY DIRECTOR

• Darren G Wilbraham

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 19, 2012
• First Posted: December 21, 2012
• Study Start: January 1, 2013
• Primary Completion: August 1, 2013
• Study Completion: August 1, 2013
• Last Updated: April 2, 2015

Record last verified: 2015-04

Locations

GB (1)