NIPH Clinical Trials Search

JRCT ID: jRCT2031210553

Registered date:17/01/2022

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

Basic Information

Recruitment status Complete
Health condition(s) or Problem(s) studiedIdiopathic pulmonary fibrosis
Date of first enrollment28/02/2022
Target sample size20
Countries of recruitment
Study typeInterventional
Intervention(s)Oral inhaled administration of S-770108


Primary OutcomeAdverse 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])
Secondary Outcome

Key inclusion & exclusion criteria

Age minimum>= 40age old
Age maximum<= 80age old
Include criteriaOutpatients 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
Exclude criteriaParticipants 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

Related Information


Public contact
Name Corporate Communications Department
Address 1-8, Doshomachi 3-chome, Chuo-ku, Osaka, Osaka Osaka Japan 541-0045
Telephone +81-6-6209-7885
Affiliation Shionogi &amp; Co., Ltd.
Scientific contact
Name Tsutae Nagata
Address 1-8, Doshomachi 3-chome, Chuo-ku, Osaka, Osaka Osaka Japan 541-0045
Telephone +81-6-6209-7885
Affiliation Shionogi &amp; Co., Ltd.