Clinical trials: sponsored by Shionogi
Hepatic Impairment
A Study to Assess S-217622 in Participants With Mild and Moderate Hepatic Impairment and Healthy Control Participants
The objective of this study is to assess the pharmacokinetics (PK), safety, and tolerability of S-217622 in participants with mild and moderate hepatic impairment compared with control participants with normal hepatic function.
- Trial name
- NCT05409911
- Testing
- S-217622
- Where
- 4 sites in United States
- Volunteers
- 25 people, healthy volunteers welcome
- Sponsor
- Shionogi
Renal Impairment
A Study to Assess S-217622 in Participants With Renal Impairment and Healthy Participants
The objective of this study is to measure the PK, safety, and tolerability of S-217622 in participants with mild, moderate, or severe renal impairment and in those with normal renal function.
- Trial name
- NCT05363215
- Testing
- S-217622
- Where
- 4 sites in United States
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- Shionogi
Diabetes Mellitus, Type 2
Study to Evaluate Safety, Tolerability, Pharmacokinetics & Pharmacodynamics of JTT-662 in Subjects With Type 2 Diabetes
This study will evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of JTT-662 administered once daily for 28 days in subjects with Type 2 diabetes mellitus (T2DM) who are receiving metformin monotherapy
- Trial name
- NCT04465877
- Testing
- JTT-662
- Where
- United States
- Volunteers
- 37 people
- Sponsor
- Shionogi Inc.
Obesity
A Study to Assess S-309309 in Healthy and Obese Participants
The primary aim of the study is to assess the safety and tolerability of S-309309 after oral administration in healthy adult or obese but otherwise healthy adult participants.
- Trial name
- NCT05247970
- Testing
- S-309309, Midazolam
- Where
- United States
- Volunteers
- 74 people, healthy volunteers welcome
- Sponsor
- Shionogi
Lung Cancer, Head and Neck Cancer
First-in-human Study of S-588210 (S-488210+S-488211)
The primary objective is to evaluate the safety and tolerability of S-588210 (S-488210+S-488211) in patients with unresectable recurrent and/or metastatic solid tumors.
- Conditions
- Lung Cancer, Head and Neck Cancer, Bladder Cancer, Esophageal Cancer
- Trial name
- NCT04316689
- Testing
- S-488210, S-488211
- Where
- United Kingdom
- Volunteers
- 10 people
- Sponsor
- Shionogi
Postoperative Gastrointestinal Dysfunction
A Study of Naldemedine in Participants Undergoing Surgeries That Include a Bowel Resection or Bowel Transection
The objective of this study is to compare the efficacy of naldemedine versus placebo and to assess its effect on the time to gastrointestinal (GI) recovery following surgeries that include bowel resection and bowel transection.
- Trial name
- NCT04355169
- Testing
- Naldemedine
- Where
- 8 sites in United States
- Volunteers
- 2 people
- Sponsor
- Shionogi
Healthy Volunteer
Evaluation of Safety, Tolerability, Pharmacokinetics, Drug-Drug and Food Interactions of Single and Multiple Doses of S-648414 in Healthy Adults
The primary objective of Part 1 of the study is to evaluate the safety and tolerability of S-648414 after administration of a single oral dose of S-648414 in healthy adult study participants.
- Trial name
- NCT04147715
- Testing
- S-648414, Midazolam, Dolutegravir
- Where
- 2 sites in United States, Japan
- Volunteers
- 98 people, healthy volunteers welcome
- Sponsor
- Shionogi
Plaque Psoriasis, Psoriasis
Study to Evaluate the Efficacy and Safety of JTE-451 in Subjects With Moderate to Severe Plaque Psoriasis
Study to evaluate the efficacy and safety of JTE-451 administered for 16 weeks in subjects with moderate to severe plaque psoriasis.
- Conditions
- Plaque Psoriasis, Psoriasis, Skin Diseases
- Trial name
- IMPACT-PS (NCT03832738)
- Testing
- JTE-451 Tablets
- Where
- 33 sites in United States, Canada and 1 more
- Volunteers
- 152 people
- Sponsor
- Shionogi Inc.
Plaque Psoriasis, Skin Diseases
Study to Evaluate the Safety and Efficacy of JTE-051 in Subjects With Moderate to Severe Plaque Psoriasis
Study to evaluate the efficacy, safety, tolerability and pharmacokinetics of JTE-051 administered for 12 weeks in subjects with moderate to severe plaque psoriasis.
- Trial name
- CLEAR-PS (NCT03358290)
- Testing
- JTE-051
- Where
- 16 sites in United States, Canada
- Volunteers
- 13 people
- Sponsor
- Shionogi Inc.
Vulvovaginal Atrophy
Women's Satisfaction and Adherence to Vulvovaginal Atrophy Treatments
The primary objective of this study is to describe and assess participants' satisfaction with current vulvovaginal atrophy (VVA) treatment.
- Trial name
- CRETA (NCT04607707)
- Where
- 3 sites in Spain
- Volunteers
- 831 people
- Sponsor
- Shionogi
Depressive Disorder
A Study of Duloxetine (LY248686) in the Treatment of Japanese Children and Adolescents With Depressive Disorder
The purpose of this long-term study is to evaluate the safety and efficacy of duloxetine hydrochloride in Japanese children and adolescents with depressive disorder.
- Trial name
- NCT03395353
- Testing
- Duloxetine Hydrochloride
- Where
- Japan
- Volunteers
- 151 people
- Sponsor
- Shionogi
Rheumatoid Arthritis
Study to Evaluate Efficacy, Safety and Tolerability of JTE-051 in Subjects With Active Rheumatoid Arthritis
This study will evaluate the efficacy, safety, tolerability and pharmacokinetics (PK) of JTE-051 administered for 12 weeks in subjects with active rheumatoid arthritis who are receiving background non-biologic disease-modifying…
- Trial name
- MOVE-RA (NCT02919475)
- Testing
- JTE-051
- Where
- 39 sites in United States, Argentina and 8 more
- Volunteers
- 260 people
- Sponsor
- Shionogi Inc.
Immune Thrombocytopenia (ITP)
A Study to Investigate the Efficacy and Safety of Lusutrombopag (S-888711) Tablets Administered to Adults With Immune Thrombocytopenia (ITP)
The primary objective of this study was to assess the efficacy of 3 dose levels of lusutrombopag (0.5 mg, 0.75 mg, and 1.0 mg) and placebo on platelet count.
- Trial name
- NCT01054443
- Testing
- Lusutrombopag
- Where
- 19 sites in United States
- Volunteers
- 20 people
- Sponsor
- Shionogi
Immune Thrombocytopenia
An Open-label Safety Study of Lusutrombopag (S-888711) in Adults With Chronic Immune Thrombocytopenia (ITP)
The primary objective of this study was to assess the long-term safety of lusutrombopag in the treatment of adults with relapsed persistent or chronic ITP with or without prior splenectomy.
- Trial name
- NCT01129024
- Testing
- Lusutrombopag
- Where
- 19 sites in United States
- Volunteers
- 19 people
- Sponsor
- Shionogi
Healthcare-associated Pneumonia (HCAP), Bloodstream Infections (BSI)
Study of Cefiderocol (S-649266) or Best Available Therapy for the Treatment of Severe Infections Caused by Carbapenem-resistant Gram-negative Pathogens
This study is designed to provide evidence of efficacy of cefiderocol in the treatment of serious infections in adult patients caused by carbapenem-resistant Gram-negative pathogens.
- Conditions
- Healthcare-associated Pneumonia (HCAP), Bloodstream Infections (BSI), Hospital Acquired Pneumonia (HAP), Complicated Urinary Tract Infection (cUTI)
- Trial name
- CREDIBLE - CR (NCT02714595)
- Testing
- Cefiderocol, Best Available Therapy
- Where
- 85 sites in United States, Brazil and 14 more
- Volunteers
- 152 people
- Sponsor
- Shionogi
Depressive Disorder
A Study of Duloxetine (LY248686) in Japanese Children and Adolescents With Depressive Disorder
The purpose of this study is to determine the efficacy of duloxetine hydrochloride versus placebo in the treatment of Japanese children and adolescents with depressive disorder.
- Trial name
- NCT03315793
- Testing
- Duloxetine Hydrochloride
- Where
- Japan
- Volunteers
- 149 people
- Sponsor
- Shionogi
Healthy Volunteer
Study in Healthy Adults to Quantify Lung Deposition and Distribution of Radio-labelled 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…
- Trial name
- NCT04631354
- Testing
- Radio-labelled S-770108, S-770108 Inhaler A1
- Where
- United Kingdom
- Volunteers
- 12 people, healthy volunteers welcome
- Sponsor
- Shionogi
Healthcare-associated Pneumonia (HCAP), Hospital Acquired Pneumonia (HAP)
Clinical Study of Cefiderocol (S-649266) for the Treatment of Nosocomial Pneumonia Caused by Gram-negative Pathogens
The primary objective of this study is to compare all-cause mortality at Day 14 in participants receiving cefiderocol with participants receiving the comparator, meropenem, in adults with hospital-acquired bacterial pneumonia…
- Conditions
- Healthcare-associated Pneumonia (HCAP), Hospital Acquired Pneumonia (HAP), Ventilator Associated Pneumonia (VAP)
- Trial name
- APEKS-NP (NCT03032380)
- Testing
- Cefiderocol, Meropenem, Linezolid
- Where
- 119 sites in United States, Belgium and 17 more
- Volunteers
- 300 people
- Sponsor
- Shionogi
Bacterial Pneumonia
Cefiderocol Concentrations in the Lungs of Hospitalized Patients With Bacterial Pneumonia
The primary purpose of the study is to determine the degree of penetration of cefiderocol into infected lung tissue in hospitalized adults with bacterial pneumonia who are being mechanically ventilated.
- Trial name
- NCT03862040
- Testing
- Cefiderocol, Standard of Care Antibiotic
- Where
- 7 sites in United States
- Volunteers
- 7 people
- Sponsor
- Shionogi
Bacterial Infections
Expanded Access to Cefiderocol for the Intravenous Treatment of Severe Gram Negative Bacterial Infections
Expanded access may be provided for cefiderocol for qualified patients who have limited treatment options and are not eligible for a clinical trial.
- Trial name
- NCT03780140
- Testing
- Cefiderocol
- Sponsor
- Shionogi