Clinical trials: sponsored by Shionogi
Amyotrophic Lateral Sclerosis, ALS
Radicava® (Edaravone) Findings in Biomarkers From ALS (REFINE-ALS)
REFINE-ALS is a prospective, observational, longitudinal, multicenter study designed to identify biomarkers to serve as quantifiable biological non-clinical measures of Edaravone effects in ALS.
- Trial name
- NCT04259255
- Testing
- Edaravone (Radicava®/Radicava ORS®)
- Where
- 20 sites in United States, Canada
- Volunteers
- 74 people
- Sponsor
- Shionogi
Pompe Disease
Study of S-606001 as an Add-on to Enzyme Replacement Therapy (ERT) in Participants With Late-onset Pompe Disease (LOPD)
The purpose of this study is to evaluate the safety, pharmacodynamics (PD), and exploratory clinical efficacy of S-606001 in adult participants with LOPD as an add-on to ERT.
- Trial name
- NCT07123155
- Testing
- S-606001
- Where
- 28 sites in United States, Belgium and 7 more
- Volunteers
- 45 people
- Sponsor
- Shionogi
Jordan's Syndrome, PPP2R5D Neurodevelopmental Disorder
Study of Zatolmilast (BPN14770) in Participants With PPP2R5D Neurodevelopmental Disorder (Jordan's Syndrome [JS])
The primary objective of this study is to assess the efficacy, safety, and tolerability of BPN14770 in participants aged 9 to 45 years with JS.
- Trial name
- NCT06717438
- Testing
- BPN14770
- Where
- 3 sites in United States
- Volunteers
- 30 people
- Sponsor
- Shionogi
Sleep Apnea
Safety and Efficacy Study of Sivopixant, Acetazolamide and SASS-001 in Sleep Apnea
The primary purpose of this study is to evaluate the effectiveness of sivopixant, acetazolamide and SASS-001 in adults with sleep apnea with a central component.
- Trial name
- NCT06776432
- Testing
- Sivopixant, Acetazolamide, SASS-001
- Where
- 9 sites in United States
- Volunteers
- 60 people
- Sponsor
- Shionogi
Solid Tumors
S-531011 as Monotherapy and in Combination With an Immune Checkpoint Inhibitor in Advanced or Metastatic Solid Tumors
The primary objective of Part A is to evaluate the safety and tolerability of S-531011 and to determine the maximum tolerated dose (MTD) and/or recommended Phase 2 dose (RP2D) of S-531011 with or without pembrolizumab.
- Trial name
- aCCeleR8-001 (NCT05101070)
- Testing
- S-531011, Pembrolizumab, Bevacizumab
- Where
- 8 sites in United States, Japan
- Volunteers
- 282 people
- Sponsor
- Shionogi
Gram-Negative Bacterial Infections
A Study to Assess the Safety, Tolerability, and Pharmacokinetics of Cefiderocol in Hospitalized Neonates and Infants
The primary purpose of this study is to understand the pharmacokinetics (PK) of single and multiple doses of cefiderocol in children from birth to less than 3 months of age with suspected or confirmed aerobic Gram-negative…
- Trial name
- NCT06086626
- Testing
- Cefiderocol, Standard of Care
- Where
- 4 sites in United States, South Africa and 1 more
- Volunteers
- 30 people
- Sponsor
- Shionogi
Renal Impairment
Study of BPN14770 in Participants With Severe Renal Impairment and Healthy Controls
The purpose of this study is to assess the pharmacokinetics (PK), safety, and tolerability of BPN14770 in participants with severe renal impairment and those with normal renal function.
- Trial name
- NCT07012005
- Testing
- BPN14770
- Where
- 2 sites in United States
- Volunteers
- 14 people, healthy volunteers welcome
- Sponsor
- Shionogi
Hepatic Impairment
Phase 1 Study of BPN14770 in Participants With Hepatic Impairment and Healthy Controls
The primary purpose of this study is to assess the pharmacokinetics (PK) of BPN14770 after a single oral administration of BPN14770 in participants with mild, moderate, and severe liver impairment compared with control…
- Trial name
- NCT07018492
- Testing
- BPN14770
- Where
- 3 sites in United States
- Volunteers
- 32 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
Bacterial Infections
P1, DDI & MAD PK and Safety Study of Xeruborbactam Oral Prodrug in Combo With Ceftibuten in Healthy Participants
A Phase 1, Open-Label, Drug-drug Interaction, and Randomized, Double-blind, Controlled, Multiple-dose Pharmacokinetics and Safety Study of Xeruborbactam Oral Prodrug (QPX7831) in Combination with Ceftibuten in Healthy Adult…
- Trial name
- NCT06079775
- Testing
- Xeruborbactam Oral Prodrug, Ceftibuten
- Where
- Australia
- Volunteers
- 53 people, healthy volunteers welcome
- Sponsor
- Qpex Biopharma, Inc.
Bacterial Infections
A DDI Study to Investigate PK and Safety of Cefiderocol in Combination With Xeruborbactam in Healthy Adult Participants
A phase 1, randomized, double blind, placebo controlled drug-drug interaction, pharmacokinetics and safety study of cefiderocol in combination with xeruborbactam in healthy adult participants
- Trial name
- NCT06547554
- Testing
- Xeruborbactam, Cefiderocol, Xeruborbactam/Cefiderocol
- Where
- United States
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- Qpex Biopharma, Inc.
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
Healthy Participants
A Study of S-740792 in Healthy Adult Study Participants
This is a 3-part study of S-740792 in healthy adult participants. Part 1 (single-ascending-dose and food effect) will investigate the safety, tolerability, and pharmacokinetics (PK) of S-740792.
- Trial name
- NCT06724978
- Testing
- S-740792 Suspension, Midazolam, S-740792 Tablet
- Where
- United States
- Volunteers
- 99 people, healthy volunteers welcome
- Sponsor
- Shionogi
ADME
Mass Balance Study of [14C]Xeruborbactam (QPX7728) in Healthy Adult Male Participants
This is a single-dose, phase 1 open-label study to determine the mass balance recovery and metabolic profiling and identification for intravenous (IV) administered [14C]xeruborbactam.
- Trial name
- NCT07083817
- Testing
- [14C]Xeruborbactam
- Where
- United Kingdom
- Volunteers
- 8 people, healthy volunteers welcome
- Sponsor
- Qpex Biopharma, Inc.
Healthy Participants
A Study to Assess the Effects of BPN14770 on Rosuvastatin
The primary objective of this study is to investigate the effects of BPN14770 on the pharmacokinetics of the breast cancer resistance protein and organic anion transporting polypeptide 1B1 substrate rosuvastatin in healthy adults.
- Trial name
- NCT07011992
- Testing
- Rosuvastatin, BPN14770
- Where
- United States
- Volunteers
- 12 people, healthy volunteers welcome
- Sponsor
- Shionogi
Gram-negative Bacterial Infections, Hospital Acquired Bacterial Pneumonia (HABP)
A Study to Assess the Safety, Tolerability, and Pharmacokinetics of Cefiderocol in Hospitalized Pediatric Participants
The primary objectives of this study are to assess the safety, tolerability, and pharmacokinetics (PK) of cefiderocol after single-dose administration in hospitalized pediatric participants 3 months to < 12 years of age with…
- Conditions
- Gram-negative Bacterial Infections, Hospital Acquired Bacterial Pneumonia (HABP), Complicated Urinary Tract Infection (cUTI), Ventilator Associated Bacterial Pneumonia (VABP)
- Trial name
- NCT04215991
- Testing
- Cefiderocol, Standard of Care
- Where
- 25 sites in United States, Australia and 8 more
- Volunteers
- 91 people
- Sponsor
- Shionogi
Bacterial Infections
PK & Safety Study of Xeruborbactam Oral Prodrug Combined With Ceftibuten in Participants With Renal Impairment
A Phase 1, open-label, single-dose study to determine the safety and pharmacokinetics of ORAvance (ceftibuten/xeruborbactam oral prodrug [QPX7831]) in participants with renal impairment
- Trial name
- NCT06157242
- Testing
- Xeruborbactam Oral Prodrug, Ceftibuten
- Where
- 2 sites in United States
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- Qpex Biopharma, Inc.
RSV Infections
A Study to Investigate How Respiratory Syncytial Virus (RSV) Infection Develops and Changes Over Time in Pediatric Participants
The primary purpose of this study is to observe how viral load and titer change over time in participants with RSV and how data from hospitalized participants compares with data from non-hospitalized participants.
- Trial name
- NCT06746051
- Where
- 2 sites in United States
- Volunteers
- 100 people
- Sponsor
- Shionogi
Healthy Adult Female Participants
A Drug-Drug Interaction Study of S-217622 With Combined Oral Contraceptives in Healthy Adult Female Participants
The purpose of this study is to examine the potential for drug-drug interactions.
- Trial name
- NCT06775730
- Testing
- Ensitrelvir
- Where
- United States
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Shionogi
Obesity
Safety and Efficacy Study of S-309309 in Obese Adults
The primary objective of this study is to understand the efficacy of S-309309 on the body weight of obese adults.
- Trial name
- NCT05925114
- Testing
- S-309309
- Where
- 49 sites in United States
- Volunteers
- 365 people
- Sponsor
- Shionogi