Healthy Volunteers Clinical Trial
Official title:
A Double Blind, Randomized, Placebo-controlled, Single Center, Parallel Group Study to Evaluate the Effects of Itopride (100 mg and 200 mg t.i.d.) on Gastric Motor and Sensory Functions in Healthy Volunteers.
A 7 day study which involves 2 nutrient drink tests, an ECG, a Scintigraphy scan, and a Sect scan. This study requires the participant to make 4 visits to the GCRC in the Charlton building but no overnight stays.
A screening interview and symptoms assessment by the Bowel Disease Questionnaire (BDQ) and
consent will be obtained prior to the studies at the testing facility (General Clinical
Research Center, 7th floor, Charlton Building, Mayo Clinic). Smoking status will be
recorded. Vitals and an electrocardiogram will be obtained. Following an initial screening,
subjects will be randomized to itopride or identical placebo.
Day 1: The participant will report in a fasting condition (10 hours) to the study center
early in the morning. All participants will undergo the nutrient drink test to assess
maximum tolerated volume and postprandial symptoms PRIOR to ingesting any medication.
Day 2-7: The patients will take the study medication as prescribed that is a tablet 30
minutes before meals, three times per day. On days 6, 7 and 8, the morning and midday dose
of the medication intake will occur in the clinical research center under supervision of the
study staff.
Day 6: The participant will return fasting for 10 hours to the study center early in the
morning. Scintigraphic gastric and small bowel transit measurement will be performed, with
medication ingested at standard times (30 min prior to meal), and the 99mTc-sulfur colloid
labeled egg meal ingested 30 minutes after the morning dose of study medication. Imaging
will be taken for 6 hours. Vitals and an electrocardiogram will be obtained Day 7: All
participants will undergo a repeat nutrient drink test to assess postprandial symptoms at
maximal satiety and 30 minutes after drug ingestion. The satiety study will be completed
once a maximum tolerated volume is achieved, and the 30 minute post-meal questionnaire will
be completed.
Day 8: The participant will return fasting to the study center early in the morning.
Participants will undergo SPECT imaging to evaluate fasting gastric volume starting 30
minutes after ingestion of study medication. The participant will then ingest 300 ml of the
nutrient drink Ensure", and postprandial gastric volumes will be calculated as described
previously (41-46). Vitals will be obtained.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT05001152 -
Taste Assessment of Ozanimod
|
Phase 1 | |
| Completed |
NCT05029518 -
3-Way Crossover Study to Compare the PK (Pharmokinetics) and to Evaluate the Effect of Food on the Bioavailability
|
Phase 1 | |
| Completed |
NCT04493255 -
A Study to Determine the Metabolism and Elimination of [14C]E7090 in Healthy Male Participants
|
Phase 1 | |
| Completed |
NCT03457649 -
IV Dose Study to Assess the Safety, Tolerability, PK, PD and Immunogenicity of ARGX-113 in Healthy Volunteers
|
Phase 1 | |
| Completed |
NCT00995891 -
Collection of Blood, Bone Marrow, and Buccal Mucosa Samples From Healthy Volunteers for Center for Human Immunology, Autoimmunity, and Inflammatory Diseases (CHI) Laboratory Research Studies
|
||
| Completed |
NCT05050318 -
Annual Study for Collection of Serum Samples in Children and Older Adults Receiving the 2021-2022 Formulations of Fluzone Quadrivalent Vaccine and Fluzone High-Dose Quadrivalent Vaccine, Respectively
|
Phase 4 | |
| Completed |
NCT05043766 -
Evaluation of Oral PF614 Relative to OxyContin
|
Phase 1 | |
| Completed |
NCT04466748 -
A Multiple Ascending Dose Pharmacology Study of Anaprazole in Healthy Chinese Subjects
|
Phase 1 | |
| Completed |
NCT00746733 -
Vyvanse and Adderall XR Given Alone and in Combination With Prilosec OTC
|
Phase 1 | |
| Recruiting |
NCT05929651 -
Study of Immunogenicity and Safety of MenQuadfi® as a Booster Vaccine in Toddlers 12 to 23 Months, Regardless of the Quadrivalent Meningococcal Conjugate Vaccine Used for Priming in Infancy
|
Phase 4 | |
| Completed |
NCT05954039 -
Evaluation of the Efficacy of a Dietary Supplement on Hair Loss and Hair Aspect
|
N/A | |
| Completed |
NCT05045716 -
A Study of Subcutaneous Lecanemab in Healthy Participants
|
Phase 1 | |
| Active, not recruiting |
NCT02747927 -
Efficacy, Safety and Immunogenicity of Takeda's Tetravalent Dengue Vaccine (TDV) in Healthy Children
|
Phase 3 | |
| Completed |
NCT05533801 -
A Study to Demonstrate the Bioequivalence of Lecanemab Supplied in Vials and a Single-Use Auto-Injector (AI) in Healthy Participants
|
Phase 1 | |
| Not yet recruiting |
NCT03931369 -
Adaptation of Thirst to a Single Administration of Tolvaptan (TOLVATHIRST)
|
Phase 2 | |
| Completed |
NCT03279146 -
A Single Dose Study Evaluating PK of TXL Oral Formulations in Healthy Subjects
|
Phase 1 | |
| Completed |
NCT06027437 -
A Study to Assess the Relative Biological Availability and the Effect of Food on the Drug Levels of Danicamtiv in Healthy Adult Participants
|
Phase 1 | |
| Recruiting |
NCT05619874 -
Effects of Two Virtual HIFCT Programs in Adults With Abdominal Obesity
|
N/A | |
| Completed |
NCT05553418 -
Investigational On-body Injector Clinical Study
|
N/A | |
| Completed |
NCT04092712 -
Study Evaluating Pharmacokinetics and Mass Balance of [14C]-CTP-543 in Healthy Adult Male Volunteers
|
Phase 1 |