Clinical trials: sponsored by Shionogi
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
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
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
Urinary Tract Infections
A Study of Efficacy and Safety of Intravenous Cefiderocol (S-649266) Versus Imipenem/Cilastatin in Complicated Urinary Tract Infections
The purpose of this study was to determine the efficacy and safety of intravenous cefiderocol (S-649266) in hospitalized adults with complicated urinary tract infections caused by Gram-negative pathogens.
- Trial name
- APEKS-cUTI (NCT02321800)
- Testing
- Cefiderocol, Imipenem/cilastatin
- Volunteers
- 452 people
- Sponsor
- Shionogi
Influenza
Study of S-033188 (Baloxavir Marboxil) Compared With Placebo or Oseltamivir in Patients With Influenza at High Risk of Influenza Complications
The primary objective of this study is to evaluate the efficacy of a single, oral dose of baloxavir marboxil compared with placebo by measuring the time to improvement of influenza symptoms in patients with influenza presenting…
- Trial name
- CAPSTONE 2 (NCT02949011)
- Testing
- Baloxavir Marboxil, Oseltamivir
- Volunteers
- 2,184 people
- Sponsor
- Shionogi
Influenza
A Study of S-033188 (Baloxavir Marboxil) Compared With Placebo or Oseltamivir in Otherwise Healthy Patients With Influenza
The primary objective of this study is to evaluate the efficacy of a single, oral dose of baloxavir marboxil compared with placebo by measuring the time to alleviation of symptoms in patients with uncomplicated influenza virus…
- Trial name
- CAPSTONE 1 (NCT02954354)
- Testing
- Baloxavir Marboxil, Oseltamivir
- Volunteers
- 1,436 people
- Sponsor
- Shionogi
Vaginal Dryness
Study to Evaluate Ospemifene in Patients With Moderate to Severe Vaginal Dryness Due to Menopause
The objective of this study is to evaluate the efficacy and safety of ospemifene 60 mg once daily (QD) compared with placebo in treatment of vulvo-vaginal atrophy (VVA) due to menopause in women with moderate to severe vaginal…
- Trial name
- NCT02638337
- Testing
- Ospemifene
- Volunteers
- 631 people
- Sponsor
- Shionogi
Healthy Volunteer
Effect of Food and Calcium on Pharmacokinetics of a Single Dose of S-888711 in Healthy Adult Volunteers
The primary objectives of this study were: To assess the effect of a high-fat diet on the pharmacokinetics (PK) of a 0.75 mg single dose of S-888711 orally administered as 0.25 mg tablets in healthy volunteer adults To assess the…
- Trial name
- NCT03897413
- Testing
- S-888711, Calcium Antacid
- Where
- United States
- Volunteers
- 15 people, healthy volunteers welcome
- Sponsor
- Shionogi
Chronic Liver Disease, Thrombocytopenia
Safety and Efficacy Study of Lusutrombopag for Thrombocytopenia in Patients With Chronic Liver Disease Undergoing Elective Invasive Procedures
The primary purpose of this study is to compare the efficacy of lusutrombopag with placebo for the treatment of thrombocytopenia in patients with chronic liver disease who are undergoing elective invasive procedures.
- Trial name
- L-PLUS 2 (NCT02389621)
- Testing
- Lusutrombopag
- Volunteers
- 215 people
- Sponsor
- Shionogi