Safety, Tolerability and Pharmacokinetics of PUR1900 (Itraconazole Powder) in Healthy Volunteers and Adults With Asthma

Summary

Phase 1, 3-part study to assess safety, tolerability and PK of single and multiple doses of itraconazole administered as a dry powder for inhalation (PUR1900) in healthy subjects (parts 1 and 2) and a 2-period crossover study of single doses of itraconazole administered as a dry powder for inhalation (PUR1900) and an oral solution (Sporanox) in adults with mild to moderate, stable asthma (part 3)

Timeline

Start

2018-02-09

Primary completion

2018-06-28

Completion

2018-06-28

Publications

• Bergagnini-Kolev M, Kane K, Templeton IE, Curran AK. Evaluation of the Potential for Drug-Drug Interactions with Inhaled Itraconazole Using Physiologically Based Pharmacokinetic Modelling, Based on Phase 1 Clinical Data. AAPS J. 2023 Jun 21;25(4):62. doi: 10.1208/s12248-023-00828-z.

Drugs

Indications