Clinical trials: sponsored by Shionogi
Renal Impairment
A Study of S-892216-PO in Participants With Renal Impairment and Matched Controls
The purpose of this study is to measure the pharmacokinetics, safety, and tolerability of S-892216 (S-892216-PO) in participants with mild, moderate, or severe renal impairment not on dialysis, or renal impairment requiring…
- Trial name
- NCT07217886
- Testing
- S-892216-PO
- Where
- 4 sites in United States
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Shionogi
Healthy Participants
Study of S-892216 Long-acting Injectable (LAI) in Healthy Adult Participants
The purpose of this study is to investigate the safety, tolerability, and pharmacokinetics (PK) of single- and multiple-dose administration of S-892216-LAI in healthy adults.
- Trial name
- NCT07093580
- Testing
- S-892216-LAI
- Where
- 3 sites in United States
- Volunteers
- 128 people, healthy volunteers welcome
- Sponsor
- Shionogi
SARS-CoV-2 Infection
Phase 3 Study of S-217622 in Prevention of Symptomatic SARS-CoV-2 Infection
The purpose of this study is to measure the proportion of participants who are infected with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) (positive reverse transcription polymerase chain reaction [RT-PCR] test)…
- Trial name
- SCORPIO-PEP (NCT05897541)
- Testing
- S-217622
- Where
- 178 sites in United States, Argentina and 3 more
- Volunteers
- 3,701 people, healthy volunteers welcome
- Sponsor
- Shionogi
Renal Impairment
Study of Sulthiame (S-054502) in Participants With Renal Impairment and Matched Healthy Controls
The purpose of this study is to evaluate the pharmacokinetics (PK), safety, and tolerability of sulthiame in participants with mild and moderate renal impairment compared to those in healthy participants with normal renal…
- Trial name
- NCT07857837
- Testing
- Sulthiame
- Where
- 2 sites in United States
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Shionogi
Healthy Adult Subjects
Study of Oral Edaravone in Healthy Adult Males
To evaluate the pharmacokinetics safety, and tolerability of single and multiple doses of edaravone solution and suspension in healthy adult males
- Trial name
- NCT04481750
- Testing
- MT-1186
- Where
- Japan
- Volunteers
- 74 people, healthy volunteers welcome
- Sponsor
- Shionogi
Hepatic Impairment, Healthy
Pharmacokinetics Study of MCI-186 in Subjects With Mild or Moderate Hepatic Impairment
To assess the pharmacokinetics of MCI-186 after a single intravenous infusion of 30mg/hour in subjects with mild or moderate Hepatic impairment compared to subjects with normal hepatic function
- Trial name
- NCT03289234
- Testing
- MCI-186
- Where
- 2 sites in Japan
- Volunteers
- 22 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
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
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
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
Healthy Adult Subjects
Clinical Pharmacology Study of Oral Edaravone in Healthy Adult Males (Drug Interaction Study and Preliminary Regimen-Finding Study)
Cohort 1: To evaluate the drug interactions, safety, and tolerability of oral edaravone when coadministered with rosuvastatin, sildenafil or furosemide in healthy adult males Cohort 2: To evaluate the pharmacokinetics, safety…
- Trial name
- NCT04481789
- Testing
- MT-1186, Rosuvastatin, Sildenafil
- Where
- Japan
- Volunteers
- 84 people, healthy volunteers welcome
- Sponsor
- 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
A Study to Evaluate the Effect of MCI-186 at Therapeutic and Supra-Therapeutic Doses on the QT Interval(QT)/Corrected QT Interval(QTc) Interval in Healthy Subjects
To evaluate the effect of MCI-186 on the QT interval corrected for heart rate using Fridericia's formula (QTcF)
- Trial name
- NCT04029090
- Testing
- MCI-186
- Where
- Japan
- Volunteers
- 27 people, healthy volunteers welcome
- 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
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
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
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