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| ID | Type | Description | Link |
|---|---|---|---|
| 2018-004469-15 | EudraCT Number |
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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)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sequence A | Experimental | Participants will receive a single dose of two radio-labelled 6 mg S-770108 capsules (total 12 mg per dose), by oral inhalation using a S-770108 inhaler at a target peak inspiratory flow rate (PIFR) of 15 L/minute on Day 1 of Period 1 followed by a single dose of two radio-labelled 6 mg S-770108 capsules by oral inhalation at a target PIFR of 30 L/minute on Day 1 of Period 2. There will be a 5 to 13 day washout period between the two treatment periods. |
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| Sequence B | Experimental | Participants will receive a single dose of two radio-labelled 6 mg S-770108 capsules (total 12 mg per dose), by oral inhalation using a S- 770108 inhaler at a target PIFR of 30 L/minute on Day 1 of Period 1 followed by a single dose of two radio-labelled 6 mg S-770108 capsules by oral inhalation at a target PIFR of 15 L/minute on Day 1 of Period 2. There will be a 5 to 13 day washout period between the two treatment periods. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Radio-labelled S-770108 | Drug | 99mTc radio-labelled S-770108 supplied as a capsule containing 6 mg active pirfenidone for inhalation |
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| Measure | Description | Time Frame |
|---|---|---|
| Total lung deposition of 99mTc radio-labelled S-770108 | Deposition of 99mTc radio-labelled S-770108 in both lungs will be assessed using gamma scintigraphy imaging. | Day 1 of each treatment period |
| Measure | Description | Time Frame |
|---|---|---|
| Central lung deposition of 99mTc radio-labelled S-770108 | Deposition of 99mTc radio-labelled S-770108 in both lungs will be assessed using gamma scintigraphy imaging. | Day 1 of each treatment period |
| Peripheral lung deposition of 99mTc radio-labelled S-770108 |
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Inclusion Criteria:
Subjects who are able to understand this study and comply with all study procedures, are able to be trained and use the device correctly at screening and willing to provide written informed consent before screening.
Subjects judged to be healthy by the principal or sub investigator, based on medical history and clinical evaluation.
Male and female subjects ≥ 40 to ≤ 80 years of age at the time of informed consent.
Subjects whose body mass index (BMI) is ≥ 18.0 and < 30.0 kg/m2 during the screening visit.
Subjects able to produce a peak inspiratory flow rate of at least 30.00L/min at screening using the investigational device attached to an electronic flow meter.
Subjects who have smoked within 12 months before admission cannot be entered the study.
Subjects judged to have normal lung function. Specifically, with percent predicted forced expiratory volume in 1 second (%FEV1) ≥ 80% and forced expiratory volume in 1 second (FEV1)/forced vital capacity (FVC) ratio ≥70%.
Male subjects are eligible to participate if they agree to the following during the treatment period and for at least 3 months (a spermatogenesis cycle) after the last dose of study intervention.
Female subjects who agree to use of appropriate contraception measures from time of screening until 3 months after the last dose of study drug, except for female subjects who are surgically sterile by bilateral oophorectomy for at least 6 weeks with appropriate documentation or who are post-menopausal (defined as at least 6 months of spontaneous amenorrhea in woman > 45 years with serum follicle-stimulating hormone (FSH) levels > 40 mIU/mL at screening, or at least 12 months of spontaneous amenorrhea in woman > 45 years)
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Shionogi Clinical Trials Administrator Clinical Support Help Line | Shionogi | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Simbec-Orion | Merthyr Tydfil | Merthyr Tydfil | CF48 4DR | United Kingdom |
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| S-770108 Inhaler A1 | Device | Dry powder inhaler |
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Deposition of 99mTc radio-labelled S-770108 in both lungs will be assessed using gamma scintigraphy imaging. |
| Day 1 of each treatment period |
| Penetration index of 99mTc radio-labelled S-770108 | Ratio of peripheral to central deposition, assessed using gamma scintigraphy imaging. | Day 1 of each treatment period |
| Extra-pulmonary deposition of 99mTc radio-labelled S-770108 | Extra-pulmonary deposition including stomach deposition, oropharyngeal deposition, retention in the device and capsules, and exhaled air filter deposition. | Day 1 of each treatment period |
| Number of device deficiencies | Device Deficiencies are defined as inadequacies of the investigational medical device with respect to its identity, quality, durability, reliability, safety or performance; for example: malfunctions, use errors, and inadequate labelling in the information supplied by the manufacturer. | Day 1 of each treatment period |
| Number of participants with adverse events | From first dose of study drug to 14 days after last dose. |