A Phase 1 interventional study of AZD7624 and Placebo to match in Chronic Obstructive Pulmonary Disease (COPD), sponsored by AstraZeneca. Completed at 1 site in United Kingdom. Open to participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2015-04-02.
Sponsored by AstraZeneca · Phase 1, Interventional, and Basic science
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.
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
2,592 studies on the registry are indexed under Lung Diseases, Obstructive; 198 are open to participants now.
This study's enrollment of 57 is below the median of 66 across 1,837 interventional studies indexed under Lung Diseases, Obstructive.
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Of its 357 completed or terminated interventional studies of FDA-regulated products, 173 (48%) have results posted.
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Exclusion Criteria:
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
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 IMP via a nebulizer
Single dose inhaled Placebo via a nebulizer
Safety variables (adverse events, vital signs, body temperature, ECGs, clinical laboratory safety tests and spirometry)
Time frame: up to 55 days.
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
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.
This study is completed, as verified in Apr 2015. You cannot join it, but the record below documents what was studied.
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