Phase 1
Completed N=47
To Assess the Safety, Tolerability, and Pharmacokinetics of AZD7624 in Healthy Volunteers and COPD Patients
Chronic Obstructive Pulmonary Disease · Healthy Subjects
Source: ClinicalTrials.gov NCT01817855 ↗
Enrolled (actual)
47
Serious AEs
0.0%
Results posted
Mar 2016
Primary outcomePrimary: Adverse Events — 6; 3; 7; 2 Participants
Summary
This study will investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of multiple ascending doses of AZD7624 in healthy subjects and patients with chronic obstructive pulmonary disease.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Adverse Events |
6; 3; 7; 2; 0; 0 | — |
| SECONDARY Summary of Pharmacokinetic Parameters (AUC(0-tau) ) |
40.1; 27.4; 13.3; 3.88; 9.31; 15.2 | — |
| SECONDARY Summary of Pharmacokinetic Parameters (Cmax) |
11.9; 15.6; 3.08; 2.14; 6.23; 8.07 | — |
| SECONDARY Summary of Pharmacokinetic Parameters (Cmin) |
0.797; 0.602; 0.355; 0.183; 0.453; 0.719 | — |
Eligibility Criteria
Inclusion Criteria
- Healthy male and/or female subjects aged 18 to 55 years (inclusive) with suitable veins for cannulation or repeated venipuncture.
- Provision of signed and dated, written informed consent prior to any study specific procedures
- Plasma myoglobin and CK not above the upper reference range of the analysing laboratory at Day -1
- Male and/or female patients with COPD aged above18 years with suitable veins for cannulation or repeated venipuncture.
- Clinical diagnosis of COPD for more than 1 year at Visit 1, according to the Global Initiative for Chronic Obstructive Lung Disease (GOLD) guidelines
Exclusion Criteria
- Any clinically important illness, medical/surgical procedure or trauma within 4 weeks of the first administration of the IP
- Receipt of another new chemical entity (defined as a compound which has not been approved for marketing) or participation in any other clinical study that included drug treatment within at least 3 months of the first administration of the IP in this study
- Any clinically important abnormalities in clinical chemistry, haematology or urinalysis results as judged by the Investigator
- Any positive result on screening for serum hepatitis B surface antigen (HBsAg), hepatitis C antibody and human immunodeficiency virus (HIV)
- History or presence of gastrointestinal, hepatic or renal disease or any other condition known to interfere with absorption, distribution, metabolism or excretion of drugs
Data sourced from ClinicalTrials.gov (NCT01817855). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.