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

JRCT ID: jRCT2031210553

Registered date:17/01/2022

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Idiopathic pulmonary fibrosis
• Date of first enrollment: 28/02/2022
• Target sample size: 20
• Study type: Interventional
• Intervention(s): Oral inhaled administration of S-770108

Outcome(s)

• Primary Outcome: 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])

Key inclusion & exclusion criteria

• Age minimum: >= 40age old
• Age maximum: <= 80age old
• Gender: Both

Include criteria

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

Exclude criteria

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

Related Information

• Primary Sponsor: Nagata Tsutae