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Completed

NCT Number: NCT01754844

A First Time in Man Study to Asses the Safety and Tolerability 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.

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Key information

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Research Site

London, United Kingdom

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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])

Treatment and study plan

AZD7624

Drug

Single dose inhaled IMP via a nebulizer

Placebo to match

Drug

Single dose inhaled Placebo via a nebulizer

Primary outcomes

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

    Time frame: up to 55 days.

Secondary outcomes

  1. 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

  2. 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.

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study 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

Important dates

Study start
2013
Primary completion
2013
Study completion
2013
First posted
Dec 21, 2012
Registry last updated
Apr 2, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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