Evaluation of the Absolute Bioavailability and Mass Balance of CHF6001 (Tanimilast)

This is an interventional other trial for Chronic Obstructive Pulmonary Disease Read More

Inclusion Criteria:

1. Subject's written informed consent obtained prior to any study-related procedure;
2. Able to understand the study procedures, the risks involved and ability to be trained to use correctly the inhalers and to generate sufficient PIF using the In-Check device and Placebo inhaler;
3. Male subjects aged 30 to 55 years inclusive;
4. Body mass index (BMI) within the range of 18 to 35 kg/m2 inclusive;
5. Non- or ex-smoker who smoked < 5 pack years and who stopped smoking > 1 year prior to screening;
6. Good physical and mental status;
7. Vital signs at screening within limits;
8. 12-lead digitised Electrocardiogram (12-lead ECG) in triplicate considered as normal;
9. Lung function measurements within normal limits at screening;
10. Regular bowel movements at screening;
11. Males with non-pregnant Women of Childbearing Potential (WOCBP) partners: they and/or their partner of childbearing potential must be willing to use a highly effective birth control method in addition to the male condom from the signature of the informed consent and until 90 days after the follow-up visit. Males with pregnant WOCBP partner: they must be willing to use male contraception (condom) from the signature of the informed consent and until 90 days after the follow-up visit.

Exclusion Criteria:

1. Participation in another clinical trial with an investigational drug in the 3 months or 5 half-lives of that investigational drug (whichever is longer) preceding the administration of the study drug;
2. Clinically relevant and uncontrolled respiratory, cardiac, hepatic (including Gilbert syndrome), gastrointestinal, renal, endocrine, metabolic, neurologic, or psychiatric disorder;
3. Clinically relevant abnormal laboratory values;
4. Subjects with history of breathing problems;
5. Positive to HIV1 or HIV2 serology at screening;
6. Positive results from the Hepatitis serology which indicates acute or chronic Hepatitis B or Hepatitis C at screening;
7. Blood donation or blood loss (equal or more than 450 mL) less than 2 months prior screening or prior to treatment;
8. Positive urine test for cotinine;
9. Documented history of alcohol abuse within 12 months prior to screening or a positive alcohol breath test;
10. Documented history of drug abuse within 12 months prior to screening or a positive urine drug screen;
11. Intake of non-permitted concomitant medications in the predefined period;
12. Presence of any current infection, or previous infection that resolved less than 7 days prior to screening or before treatment;
13. Known intolerance and/or hypersensitivity to any of the excipients contained in the formulation used in the trial;
14. Unsuitable veins for repeated venipuncture;
15. Heavy caffeine drinker;
16. Abnormal haemoglobin level at screening;
17. Subjects using e-cigarettes within 6 months prior to screening;
18. Subjects been involved in a study involving a 14C-labeled drug within the 12 months prior to enrollment;
19. Subjects with exposure to significant diagnostic or therapeutic radiation or current employment in a job requiring radiation exposure monitoring within 12 months prior to Day-1;
20. Documented COVID-19 diagnosis within the last 8 weeks or which has not resolved within 14 days prior to screening and before treatment.