Pharmacokinetic Profile of Voriconazole Inhalation Powder in Adult Subjects With Asthma

• Status: Recruiting
• Trial end date: 2021-12-31
• Target enrollment: 0
• Participant gender: All

Summary

This is a Phase 1b, randomized, double-blind, placebo-controlled trial to evaluate the safety, tolerability, and pharmacokinetic profiles of voriconazole inhalation powder in adult subjects with well-controlled asthma. This study will involve 2 cohorts.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: TFF Pharmaceuticals, Inc.
• Treatments: Voriconazole

Criteria

Inclusion Criteria:

1. Provide written informed consent to participate and is willing and able to participate in the study and abide by study restrictions in the judgement of the Investigator.

2. Males or non-pregnant, non-lactating females.

3. Well-controlled Step 2 or Step 3 asthma defined by the GINA guidelines.

4. Body mass index (BMI) ≥ 18.0 and ≤ 35.0 kg/m2 at Screening.

5. Normal blood pressure at Screening and Check-In.

6. Normal clinical laboratory tests at Screening and Check-In.

7. Negative for hepatitis B surface antigen (HBsAg), hepatitis C antibody, human immunodeficiency virus (HIV) I and II antibodies, tuberculosis (TB), or COVID-19 at Screening.

8. Able to successfully perform spirometry and use the inhalation device, as demonstrated at Screening and Check-In.

Exclusion Criteria:

1. History or presence of clinically significant medical, ophthalmic, or psychiatric conditions or diseases in the opinion of the Investigator or designee.

2. History or current evidence of any chronic upper or lower respiratory conditions other than asthma or allergic (seasonal or perennial), or non-allergic rhinitis. History of mild acute upper or lower respiratory conditions are allowed, provided that it has been at least 3 months since the condition resolved and provided that in the Investigator's judgement, this occurrence poses no additional risk for this subject.

3. History of any illness or surgery within 6 months of Screening that, in the opinion of the Investigator, might confound the results of the study or that poses an additional risk to the subject by their participation in the study.

4. Current or former smokers, users of e-cigarettes or nicotine replacement products who have more than a 10-pack year history of smoking and who have used these products within the 6 months prior to Screening.

5. History or presence of alcoholism or drug abuse within the past 2 years prior to Screening.

6. History or presence of hypersensitivity or idiosyncratic reaction to voriconazole or any triazole antifungal.

7. Received any marketed or investigational biologic within 4 months or 5 half-lives prior to dosing, whichever is longer.

8. Received treatment with investigational study drug (or device) in another clinical study within 30 days or five half-lives of dosing, whichever is longer.

9. Subjects who have taken any of the protocol prohibited medications within 30 days of the first dose or who are expected to require these medications during the study.

10. ECG with a QTcF interval >450 msec for males or QTcF interval > 470 msec for females or ECG findings deemed clinically significantly abnormal by the Investigator prior to the first dose.

11. Unable to refrain from or anticipates the use of any vitamin supplements, prescription, over-the-counter (OTC), herbal preparations or medications other than those specified for asthma or allergic rhinitis medications, or topical ophthalmic drops beginning 14 days prior to the first dose and throughout the study.

12. Females requiring hormone replacement therapy within 30 days of Screening or during the study.

13. Allergy or sensitivity to lactose or milk products.

14. Donation of blood or blood products within the last 2 months.

15. Loss of 50 to 500 mL whole blood within the past two months.