Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Theravance Biopharma
With
Alfasigma S.p.A.
Age
18–64
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Symptoms of gastroparesis (e.g., nausea, early satiety, fullness, bloating, upper abdominal pain, retching or vomiting) for at least 3 months prior to Screening
Body Mass Index (BMI) between 18 and 35 kg/m2, inclusive
Gastroparesis Cardinal Symptom Index (GCSI-2W) composite score ≥2 and ≤4 at Screening
Delayed gastric emptying, defined as a gastric emptying half-time (GE t1/2) \> 160 minutes as determined by \[13C\]-octanoate breath test, at Screening
Upper gastrointestinal (UGI) obstruction ruled out by endoscopy or other imaging reasonably proximal to the diagnosis of gastroparesis
You may not be if
Acute severe gastroenteritis within 2 weeks prior to Screening
History of gastric outlet obstruction
Prior history of gastric surgery, including but not limited to gastrectomy, gastric bypass, gastric banding, pyloroplasty, vagotomy, or fundoplication
Recurrent vomiting, defined as vomiting more than 2 days per week
Hospitalization for treatment of gastroparesis or complications of diabetes within 4 weeks prior to Screening
Presence of thyroid dysfunction not controlled by treatment. Subjects with abnormal thyroid stimulating hormone (TSH), hypothyroidism, or hyperthyroidism at Screening
If Type 1 or Type 2 diabetic, a glycosylated hemoglobin (HbA1c) level \>10% or a glucose \> 250 mg/dL at Screening
