Clinical trials: sponsored by 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
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
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
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
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
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
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 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
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