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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT01754844
First received: December 19, 2012
Last updated: September 6, 2013
Last verified: September 2013
  Purpose

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.


Condition Intervention Phase
Chronic Obstructive Pulmonary Disease (COPD)
Drug: AZD7624
Drug: Placebo to match
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Basic Science
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

Resource links provided by NLM:


Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • Safety variables (adverse events, vital signs, body temperature, ECGs, clinical laboratory safety tests and spirometry) [ Time Frame: up to 55 days. ] [ Designated as safety issue: Yes ]

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. [ Time Frame: Day 1 pre-dose, 5min, 15min, 30min, 1h, 2h, 4h, 6h, 9h,12h, 18h, 24h, 36h, 48h, 56h post dose ] [ Designated as safety issue: No ]
  • 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. ] [ Designated as safety issue: No ]

Enrollment: 40
Study Start Date: January 2013
Study Completion Date: August 2013
Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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])
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01754844

Locations
United Kingdom
Research Site
London, United Kingdom
Sponsors and Collaborators
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
  More Information

No publications provided

Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT01754844     History of Changes
Other Study ID Numbers: D2550C00001
Study First Received: December 19, 2012
Last Updated: September 6, 2013
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by AstraZeneca:
Phase 1
Healthy Volunteers
Single Ascending Dose (SAD)
First Time in Man
Pharmacokinetics
Pharmacodynamics

Additional relevant MeSH terms:
Lung Diseases
Pulmonary Disease, Chronic Obstructive
Lung Diseases, Obstructive
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on July 31, 2014