Clinical trials: sponsored by 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
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
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
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
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
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
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
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
COVID-19
A Drug-drug Interaction Study of S-892216 Coadministered With Carbamazepime to Healthy Adult Participants
The primary objective of this study is to investigate the effect of multiple-dose administration of carbamazepine on the pharmacokinetics of S-892216 in healthy adults.
- Trial name
- NCT06751017
- Testing
- S-892216, Carbamazepine
- Where
- United States
- Volunteers
- 16 people, healthy volunteers welcome
- Sponsor
- Shionogi
Healthy Volunteers
A Study to Investigate Different Formulations of S-337395 in Healthy Adult Participants
The aim of this study is to investigate different formulations of S-337395.
- Trial name
- NCT06270511
- Testing
- S-337395
- Where
- United States
- Volunteers
- 50 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
Obesity, Healthy Volunteers
Effect of Administration of Itraconazole on the Pharmacokinetics of S-309309 in Healthy Participants
The primary purpose of this study is to determine the effect of repeated administration of itraconazole on the pharmacokinetic (PK) profile of S-309309; and the PK of S-309309 following administration of S-309309 alone and…
- Trial name
- NCT06106334
- Testing
- S309309, Itraconazole
- Where
- United States
- Volunteers
- 14 people, healthy volunteers welcome
- 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
Gram-Negative Infection
Use of Cefiderocol in the Management of Gram-Negative Infections
The aim of this study is to describe the use of cefiderocol in the management of Gram-negative infections (GNIs) in participants treated through the Early Access Program (EAP) in Spain.
- Trial name
- PERSEUS (NCT05789199)
- Testing
- Cefiderocol
- Where
- 55 sites in Spain
- Volunteers
- 314 people
- Sponsor
- 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