Trials / Completed
CompletedNCT04631354
Study in Healthy Adults to Quantify Lung Deposition and Distribution of Radio-labelled S-770108 Inhalation Powder Formulation Delivered by a Novel Inhaler Device
A Phase One Open Label, Crossover Study in Healthy Adult Subjects to Quantify Lung Deposition and Distribution of 99mTc Radiolabelled S-770108 Inhalation Powder Formulation Delivered by a Novel Inhaler Device
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 12 (actual)
- Sponsor
- Shionogi · Industry
- Sex
- All
- Age
- 40 Years – 80 Years
- Healthy volunteers
- Accepted
Summary
The primary objective of this study is to assess the total lung deposition of radiolabelled S-770108 inhalation powder formulation after each of two separate single inhaled doses in healthy adult participants at two different target peak inspiratory flow rates (PIFRs)
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Radio-labelled S-770108 | 99mTc radio-labelled S-770108 supplied as a capsule containing 6 mg active pirfenidone for inhalation |
| DEVICE | S-770108 Inhaler A1 | Dry powder inhaler |
Timeline
- Start date
- 2020-11-09
- Primary completion
- 2020-12-14
- Completion
- 2020-12-21
- First posted
- 2020-11-17
- Last updated
- 2020-12-29
Locations
1 site across 1 country: United Kingdom
Source: ClinicalTrials.gov record NCT04631354. Inclusion in this directory is not an endorsement.