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
Overview
- Phase
- Phase 1
- Intervention
- AZD7624
- Conditions
- Chronic Obstructive Pulmonary Disease (COPD)
- Sponsor
- AstraZeneca
- Enrollment
- 57
- Locations
- 1
- Primary Endpoint
- Safety variables (adverse events, vital signs, body temperature, ECGs, clinical laboratory safety tests and spirometry)
- Status
- Completed
- Last Updated
- 11 years ago
Overview
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
Investigators
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 \[intake of 20 to 600 times the recommended daily dose\])
Arms & Interventions
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.
Intervention: AZD7624
Placebo
Subjects will participate in 1 of 5 groups. In each group 6 subjects will receive AZD7624 and 2 subjects will receive matching placebo.
Intervention: Placebo to match
Outcomes
Primary Outcomes
Safety variables (adverse events, vital signs, body temperature, ECGs, clinical laboratory safety tests and spirometry)
Time Frame: up to 55 days.
Secondary Outcomes
- 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.)
- 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)