Clinical trial NCT01754844: 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
Overall status: COMPLETED
Phase: PHASE1
Conditions: Chronic Obstructive Pulmonary Disease (COPD)
Keywords: Phase 1
Healthy Volunteers
Single Ascending Dose (SAD)
First Time in Man
Pharmacokinetics
Pharmacodynamics
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2012-12-21
Enrollment: 57
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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

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

Primary outcomes:
measure: Safety variables (adverse events, vital signs, body temperature, ECGs, clinical laboratory safety tests and spirometry)
timeFrame: up to 55 days.
Secondary outcomes:
measure: 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.
timeFrame: Day 1 pre-dose, 5min, 15min, 30min, 1h, 2h, 4h, 6h, 9h,12h, 18h, 24h, 36h, 48h, 56h post dose
measure: Pharmacokinetics of single doses of AZD7624 using the following urine PK parameters: Ae and CLR
timeFrame: Day 1: during 0-6, 6-12, 12-24 and 24-48 hours post dose.
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: Research Site
Study officials:
affiliation: AstraZeneca Research and Development SE-431 83 Molndal Sweden
name: Sam Lindgren, MD
role: STUDY_DIRECTOR
affiliation: Quintiles Drug Research Unit at Guy's Hospital 6 Newcomen St London SE1 1YR
name: Darren G Wilbraham
role: PRINCIPAL_INVESTIGATOR
References: