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A Phase 1, Uncontrolled, Open Label Study in Patients with Idiopathic Pulmonary Fibrosis to Assess the Safety, Tolerability, and Pharmacokinetics of Multiple Inhaled Doses of S-770108

A Phase 1 Study of S-770108 in Patients with Idiopathic Pulmonary Fibrosis

27

In 25 participants who received the study intervention at least once, 21 (84.0%) were male participants. The mean age (SD) of the participants was 66.6 (8.8) years and the mean body mass index (BMI) (SD) was 25.18 (4.07). The median %FVC was 78.80% (range, 56.8% to 128.2%).

A total of 27 participants were enrolled in the study. Twenty-five of the participants started to receive the study intervention, while 2 participants discontinued the study before the study intervention administration. Of the 25 participants, 24 participants completed the study and 1 participant discontinued the study. The 25 participants were included in the saftey analysis population. Of 27 participants enrolled, 26 participants were included in the inspiratory profile population.

A total of 325 TEAEs were reported in 24 of 25 participants (96.0%). Of these, 321 TEAEs reported in 24 of 25 participants (96.0%) were considered related to the study intervention (ADRs). The most common TEAE was cough (96.0%). All events of cough were observed immediately after inhalation of S-770108 and promptly resolved without any treatments. No deaths or other serious TEAEs were reported during the study. One TEAE leading to discontinuation of study intervention, diarrhoea, was reported in 1 of 25 participants (4.0%). It was considered unrelated to the study intervention. No clinically significant findings or trends related to study intervention were identified in laboratory parameters, vital signs, 12-lead ECGs, pulmonary function results, or other safety observations. No adverse device effects were reported during the study.

The primary objective was to assess the safety and tolerability following multiple doses of S-770108 using ICOcap in Japanese participants with IPF. Safety results are shown in the section of Adverse events above. The secondary objective was to assess the PK following multiple doses of S-770108 using ICOcap in Japanese participants with IPF. The secondary endpoint was the mean plasma drug concentration at steady state. The geometric means for the plasma concentration of pirfenidone at 0.50 hours and 1.00 hour after study intervention administration on Day 15 were 203 ng/mL and 169 ng/mL, respectively.

Overall, multiple inhaled doses of S-770108, ie, two 6 mg capsules (12 mg was a dose) inhaled 3 times a day (12 mg/dose, 36 mg/day) for 15 (+/-3) days, were generally safe and well tolerated in Japanese IPF participants. The geometric means for the plasma concentration of pirfenidone at 0.50 hours and 1.00 hour after study intervention administration on Day 15 were 203 ng/mL and 169 ng/mL, respectively. All IPF participants achieved a peak inspiratory flow rate of 30 L/min or more using ICOcap.

June. 30, 2025

No

https://jrct.mhlw.go.jp/latest-detail/jRCT2031210553

Nagata Tsutae

Shionogi & Co., Ltd.

1-8, Doshomachi 3-chome, Chuo-ku, Osaka, Osaka

shionogiclintrials-admin@shionogi.co.jp

Corporate Communications Department

Shionogi & Co., Ltd.

1-8, Doshomachi 3-chome, Chuo-ku, Osaka, Osaka

+81-6-6209-7885

shionogiclintrials-admin@shionogi.co.jp

Complete

Jan. 25, 2022

Interventional

single arm study

open(masking not used)

uncontrolled control

single assignment

treatment purpose

Outpatients aged 40 to 80 years inclusive, at the time of signing the informed consent
Japanese participants diagnosed with IPF based on the Diagnosis of idiopathic pulmonary fibrosis: an official ATS/ERS/JRS/ALAT clinical practice guideline. Guideline (2018)
Participants with predicted %FVC of 50% or more at screening
If the participant is receiving intervention for IPF with nintedanib, participants who have continued the treatment at a stable dose for at least 4 weeks before screening

Participants with known malignancies requiring treatment
History or presence of significant disease accompanied by clinical symptoms which are considered inappropriate for participation in the study by the (sub)investigator, including metabolic, endocrine, hepatic, renal, hematological, respiratory (other than the primary disease), cardiovascular, gastrointestinal, urological, immunological, neurological and psychiatric disorders
Participants scheduled to undergo lung transplantation during the study period
Participants with airflow obstruction (FEV1/FVC ratio < 70%)
Participants requiring long term oxygen therapy (oxygen therapy performed for 15 hours or longer per day)
Prior use of oral pirfenidone within 1 week before the first dose of the study intervention (Day 1)
Prior use of drugs known to inhibit (eg, fluvoxamine maleate, ciprofloxacin, itraconazole) or induce (eg, rifampicin) drug metabolism mediated by the cytochrome P450 system within 1 month before the screening test
History of acute exacerbation of IPF

Both

Idiopathic pulmonary fibrosis

Oral inhaled administration of S-770108

Adverse events (AEs), physical examination, laboratory tests (hematology, blood chemistry, and urinalysis), vital signs (systolic/diastolic blood pressure, pulse rate, respiratory rate, and body temperature), 12 lead ECG, pulmonary function test (forced vital capacity [FVC], percent predicted forced vital capacity [%FVC], forced expiratory volume in 1 second [FEV1], and forced expiratory volume in 1 second as percent of FVC [FEV1/FVC])

+81-45-701-9581

Nov. 11, 2021

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