Clinical trials: sponsored by Shionogi
Healthy Adult Subjects
Bioequivalence Study of Oral Suspension and Intravenous Formulation of Edaravone in Healthy Adult Subjects
To evaluate the single-dose bioequivalence of oral suspension and intravenous (IV) formulation of edaravone in the fasting state in healthy adult subjects
- Trial name
- NCT04493281
- Testing
- MT-1186, MCI-186
- Where
- Japan
- Volunteers
- 42 people, healthy volunteers welcome
- Sponsor
- Shionogi
Healthy Adult Subjects
Comparative Bioavailability Study of Oral Edaravone Administered Orally and Via a Nasogastric Tube
To investigate the comparative bioavailability of edaravone oral suspension administered orally and via a nasogastric tube in healthy adult subjects
- Trial name
- NCT04776135
- Testing
- MT-1186
- Where
- Japan
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- Shionogi
Severe Hepatic Impairment, Healthy
PK Study in Subjects With Severe Hepatic Impairment
This is an open-label, single-dose study in male and female subjects with severe hepatic impairment and in male and female subjects with normal hepatic function.
- Trial name
- MCI-186-E05 HP (NCT03664544)
- Testing
- MCI-186
- Where
- 3 sites in Czechia, Hungary and 1 more
- Volunteers
- 12 people, healthy volunteers welcome
- Sponsor
- Shionogi
Healthy Adult Subjects
Clinical Pharmacology Study of Oral Edaravone in Healthy Adult Subjects (Food Effect Study)
To evaluate the effect of food on the pharmacokinetics of oral edaravone in healthy adult subjects. In this study, we determined 5 different dietary conditions including 4 different meal contents and fasting condition.
- Trial name
- NCT05342597
- Testing
- MT-1186
- Where
- Japan
- Volunteers
- 16 people, healthy volunteers welcome
- Sponsor
- Shionogi
Renal Impairment, Healthy
Pharmacokinetics Study of MCI-186 in Subjects With Mild or Moderate Renal Impairment
To assess the pharmacokinetics of MCI-186 after a single intravenous infusion of 30mg/hour in subjects with mild or moderate renal impairment compared to subjects with normal renal function.
- Trial name
- NCT03289208
- Testing
- MCI-186
- Where
- Japan
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Shionogi
Gram-negative Bacterial Infections, Bloodstream Infections (BSI)
A Study to Assess the Safety, Tolerability, and Pharmacokinetics of Single and Multiple Doses of Cefiderocol in Hospitalized Pediatric Participants
The primary objectives of this study are: To assess the safety and tolerability of cefiderocol after single-dose administration in hospitalized paediatric participants 3 months to < 18 years of age with suspected or confirmed…
- Conditions
- Gram-negative Bacterial Infections, Bloodstream Infections (BSI), Complicated Intra-abdominal Infection (cIAI), Hospital Acquired Pneumonia (HAP)
- Trial name
- NCT04335539
- Testing
- Cefiderocol, Standard of Care
- Where
- 23 sites in Belgium, Estonia and 7 more
- Volunteers
- 53 people
- Sponsor
- Shionogi
SARS-CoV-2
A Study of S-268019 for the Prevention of COVID-19
The main purpose of this study is to assess the efficacy of S-268019-b for the prevention of COVID-19 in the initial vaccination period prior to crossover in participants without evidence of infection before vaccination as…
- Trial name
- NCT05212948
- Testing
- S-268019-b
- Where
- Vietnam
- Volunteers
- 9,902 people, healthy volunteers welcome
- Sponsor
- Shionogi
Chronic Cough
Evaluation of S-600918 in Adults With Refractory Chronic Cough
The primary objective of this study is to determine the optimal dose of S-600918 in patients with refractory chronic cough by evaluating the change from baseline in 24-hour cough frequency (coughs per hour) with S-600918 compared…
- Trial name
- NCT04110054
- Testing
- S-600918
- Where
- 136 sites in United States, Czechia and 4 more
- Volunteers
- 406 people
- Sponsor
- Shionogi
Healthy Volunteers
A Study to Assess the Effect of Cefiderocol on the Pharmacokinetics (PK) of Midazolam in Healthy Participants
The purpose of this study is to determine the effect of repeated doses of cefiderocol on the PK of midazolam.
- Trial name
- NCT05395104
- Testing
- Midazolam, Cefiderocol
- Where
- United States
- Volunteers
- 14 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.
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.
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