A comparison of drug metabolism in healthy volunteers and patients with severe chronic obstructive lung disease (COPD)

Phase 4

• Conditions: Chronic obstructive Pulmonary Disease (COPD); Drug metabolism; Respiratory - Chronic obstructive pulmonary disease

• Registration Number: ACTRN12619000861156
• Lead Sponsor: Dr Richard McNeill

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-06-18
• Last Update Posted: 15 July 2019

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: All
• Target Recruitment: 24

Inclusion Criteria

Healthy volunteers:
•Age over 18 years old
•Ability to understand and the willingness to sign or verbally consent to a written or verbal informed consent document
•Ability to abstain from caffeine for 48 hours prior to the study and for the duration of the pharmacokinetic sampling
•Body mass index 18 – 30

Patients with COPD:
•COPD with GOLD D severity
•Body mass index less than or equal to 25
•Age over 18 years old
•Ability to understand and the willingness to sign or verbally consent to a written or verbal informed consent document
•Ability to abstain from caffeine for 48 hours prior to the study and for the duration of the pharmacokinetic sampling
•Ability to safely swallow tablets

Exclusion Criteria

Healthy volunteers:
•Known sensitivity or contraindications to any of the cocktail drugs
•Concomitant use of any of the study medicines (except caffeine)
•Concomitant use of medicines known to be moderate or major inhibitors or inducers of cytochrome P450
•Current smoker
•Any medical condition expected to affect study drug metabolism or ability to participate in the study
•Pregnancy

Patients with COPD:
•Known sensitivity or contraindications to any of the cocktail drugs
•Concomitant use of any of the study medicines (except caffeine)
•Concomitant use of medicines known to be moderate or major inhibitors or inducers of cytochrome P450
•Current smoker
•Liver cirrhosis
•Active hepatitis
•Significant small bowel resection
•Oral corticosteroid use in the last 2 weeks
•Exacerbation of COPD in the last 2 weeks
•Intercurrent illness expected to affect study drug metabolism
•Using domiciliary oxygen
•Active malignancy
•Pregnancy

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Area-under-the-curve (AUC) of the plasma concentration for midazolam, measured by LC-MS[Baseline, 0.25h, 0.5h, 0.75h, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, and 8h post dose.];Area-under-the-curve (AUC) of the plasma concentration for dextromethorphan, measured by LC-MS[Baseline, 0.25h, 0.5h, 0.75h, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, and 8h post dose.];Area-under-the-curve (AUC) of the plasma concentration of losartan, measured by LC-MS[Baseline, 0.25h, 0.5h, 0.75h, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, and 8h post dose.]