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

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

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2031210553

Enrollment

Registered

2022-01-17

Start date

2022-02-28

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Idiopathic pulmonary fibrosis

Interventions

Oral inhaled administration of S-770108

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion 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

Exclusion criteria

Exclusion 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

Design outcomes

Primary

Measure	Time frame
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])	—

Measure

Time frame

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])

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Contacts

Public ContactCorporate Communications Department

Shionogi & Co., Ltd.

shionogiclintrials-admin@shionogi.co.jp+81-6-6209-7885

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026