Healthy VolunteerPhase 1NCT04631354
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 1 study testing Radio-labelled S-770108 and S-770108 Inhaler A1 in people with Healthy Volunteer, run by Shionogi at 1 site in United Kingdom.
Trial 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) Read more about this study
- Who is it for?
- Ages 40 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteer
- What is being tested?
- Radio-labelled S-770108 and S-770108 Inhaler A1
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 9 Nov 2020to 21 Dec 2020
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
- Refrain from donating sperm.
- Must agree to use a male condom and should also be advised of the benefit for a female partner to use a highly effective method of contraception as described in Appendix 2, as a condom may break or leak when having sexual intercourse with a woman of childbearing potential who is not currently pregnant.
- 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)
Who cannot join
- Subjects deemed by the principal or sub investigator to be ineligible for the study due to history of, or concurrent and clinically significant metabolic or endocrine, hepatic, renal, haematological, respiratory, cardiovascular, gastrointestinal, urological, immunological, neurological or psychiatric disorders, or any malignant neoplasms at any diagnosed stage.
- Radiation exposure, including that from the present study, excluding background radiation but including diagnostic X-rays and other medical exposures, exceeding 5 mSv in the last 12 months or 10 mSv in the last 5 years. No occupationally exposed worker, as defined in the Ionising Radiation Regulations 2018, shall participate in the study.
- Subjects who have a history of clinically relevant respiratory disease, diseases affecting respiratory function, E.N.T. diseases, or lung surgery.
- Subjects who have had an upper respiratory infection in the last 7 days which could affect inhalation/absorption of study medication.
- Subjects who use regular medication (prescribed and/or over the counter) or have used any medication (excluding non-prescription drugs, vitamins, and dietary or herbal supplements which do not interfere with respiratory function according to their labelling) within 14 days before admission; exceptions may be permitted on a case by case basis if considered not to interfere with the aims of the study and agreed by the investigator and sponsor's medical monitor.
- Subjects with a history of lactose intolerance, intolerance to dairy products, or a history of gluten intolerance.
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- Subjects with a history of serious adverse reaction or serious hypersensitivity to the active ingredient or excipients in any drug.
- Subjects with a history of drug and/or alcohol addiction within the past 2 years before screening or a positive test for drugs or alcohol at screening or admission visit.
- Regular alcohol consumption in males of > 21 units per week, or females of > 14 units per week (1 unit = 1/2 pint beer, 25 mL of 40% spirit or a 125 mL glass of wine).
- Subjects with a positive result on any of the tests for the serologic detection of human immunodeficiency virus (HIV) antigen/antibody, hepatitis B surface antigen (HBsAg), and hepatitis C antibody.
- Female subjects who are pregnant, breast-feeding, have a positive pregnancy test result during the screening assessment or admissions; or intending to become pregnant during the study period or within 3 months after the last dose of study treatment.
- Subjects who have donated > 400 mL of blood within 3 months before screening, > 200 mL within 4 weeks before screening, or who donated blood between screening and admission.
- Subjects who have been exposed to an investigational drug within 90 days prior to study drug administration.
- Subjects who have previously received pirfenidone (Esbriet®, Pirespa®) in any form, or S 770108.
- Subjects who are study site employees or immediate family members of a study site employee, or sponsor employees.
- Subjects who are ineligible for the study for any other reason, as judged by the investigator or sub investigator.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Simbec-Orion
Merthyr Tydfil, Merthyr Tydfil, CF48 4DR
About this study
Official title: 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
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
- Healthy Volunteer
- Being tested
- Radio-labelled S-770108, S-770108 Inhaler A1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Radio-labelled S-770108Drug
99mTc radio-labelled S-770108 supplied as a capsule containing 6 mg active pirfenidone for inhalation
S-770108 Inhaler A1Device
Dry powder inhaler
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Radio-labelled S-770108; Device: S-770108 Inhaler A1 |
| 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. Receives: Drug: Radio-labelled S-770108; Device: S-770108 Inhaler A1 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Day 1 of each treatment period
Secondary outcomes (6)
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.
Measured: Day 1 of each treatment period
Peripheral 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Day 1 of each treatment period
Number of participants with adverse events
Measured: From first dose of study drug to 14 days after last dose.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2020
- Study start9 Nov 2020
- Primary completion14 Dec 2020
- Study completion21 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteerStudies of the same condition, open and under way.
- More trials run by ShionogiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shionogi
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Shionogi Clinical Trials Administrator Clinical Support Help Line, Study director, Shionogi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04631354
- Sponsor's protocol ID
- 1604P2111
- Other IDs
- 2018-004469-15, 2018
- Status last verified
- Dec 2020
- First submitted
- 12 Nov 2020
- Last updated
- 29 Dec 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT04631354
- Acronym / sponsor ID
- 1604P2111
- Conditions
- Healthy Volunteer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- ShionogiIndustry (pharma, biotech, devices)
- Study start
- 9 Nov 2020 (actual)
- Primary completion
- 14 Dec 2020 (actual)
- Study completion
- 21 Dec 2020 (actual)
- First posted
- 17 Nov 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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)
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sequence A | Experimental | Drug: Radio-labelled S-770108, Device: S-770108 Inhaler A1Participants 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. |
| Sequence B | Experimental | Drug: Radio-labelled S-770108, Device: S-770108 Inhaler A1Participants 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. |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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.
Key exclusion criteria (16 listed)
- Subjects deemed by the principal or sub investigator to be ineligible for the study due to history of, or concurrent and clinically significant metabolic or endocrine, hepatic, renal, haematological, respiratory, cardiovascular, gastrointestinal, urological, immunological, neurological or psychiatric disorders, or any malignant neoplasms at any diagnosed stage.
- Radiation exposure, including that from the present study, excluding background radiation but including diagnostic X-rays and other medical exposures, exceeding 5 mSv in the last 12 months or 10 mSv in the last 5 years. No occupationally exposed worker, as defined in the Ionising Radiation Regulations 2018, shall participate in the study.
- Subjects who have a history of clinically relevant respiratory disease, diseases affecting respiratory function, E.N.T. diseases, or lung surgery.
- Subjects who have had an upper respiratory infection in the last 7 days which could affect inhalation/absorption of study medication.
- Subjects who use regular medication (prescribed and/or over the counter) or have used any medication (excluding non-prescription drugs, vitamins, and dietary or herbal supplements which do not interfere with respiratory function according to their labelling) within 14 days before admission; exceptions may be permitted on a case by case basis if considered not to interfere with the aims of the study and agreed by the investigator and sponsor's medical monitor.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Radio-labelled S-77010899mTc radio-labelled S-770108 supplied as a capsule containing 6 mg active pirfenidone for inhalation | Drug | Sequence A, Sequence B |
| S-770108 Inhaler A1Dry powder inhaler | Device | Sequence A, Sequence B |
Primary outcome
Total lung deposition of 99mTc radio-labelled S-770108
Time frame: Day 1 of each treatment period
Deposition of 99mTc radio-labelled S-770108 in both lungs will be assessed using gamma scintigraphy imaging.
6 secondary outcomes
Central lung deposition of 99mTc radio-labelled S-770108
Time frame: Day 1 of each treatment period
Peripheral lung deposition of 99mTc radio-labelled S-770108
Time frame: Day 1 of each treatment period
Penetration index of 99mTc radio-labelled S-770108
Time frame: Day 1 of each treatment period
Extra-pulmonary deposition of 99mTc radio-labelled S-770108
Time frame: Day 1 of each treatment period
Number of device deficiencies
Time frame: Day 1 of each treatment period
Number of participants with adverse events
Time frame: From first dose of study drug to 14 days after last dose.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Dec 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shionogi Clinical Trials Administrator Clinical Support Help Line study director
Shionogi
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Radio-labelled S-770108 and S-770108 Inhaler A1 in people with Healthy Volunteer, run by Shionogi at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total lung deposition of 99mTc radio-labelled S-770108 (time frame: Day 1 of each treatment period). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Dec 2020.