Clinical trial NCT03900325: Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Exploratory Efficacy of Nimacimab in Patients With Diabetic Gastroparesis
Official title: A Single-Blind Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Exploratory Efficacy of Nimacimab in Patients With Diabetic Gastroparesis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Diabetic Gastroparesis
Lead sponsor: Bird Rock Bio, Inc.
Sponsor class: INDUSTRY
First posted: 2019-04-03
Enrollment: 6
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

Brief summary: This is a single blind phase 2a study to evaluate the safety, tolerability, pharmacokinetics, and exploratory efficacy of nimacimab in patients with diabetic gastroparesis.


Eligibility criteria: Inclusion Criteria:

* Diagnosed with type 1 or type 2 diabetes
* Diagnosed with diabetic gastroparesis, defined by:

  1. 3 month past or current history of symptoms of gastroparesis (e.g. nausea, vomiting, bloating, abdominal pain, or feeling full earlier than normal after eating)
  2. Screening or historical scintigraphy (3 years prior to screening) with \> 20% of solid contents retained at 4 hours.
* BMI \>= 20.0 and \< = 50.0 kg/m2

Exclusion Criteria:

* Participants on prokinetic therapy should have these medications withdrawn at least 7 days prior to any study scintigraphy exam and at least 7 days prior to the first dose through Day 15 of treatment.
* Participants with any active prokinetic device are excluded, unless device is turned off for at least 7 days prior to any study scintigraphy exam and at least 7 days prior to the first dose through Day 15 of treatment.
* Participants who are currently participating in or have participated in a study of an investigational agent or has used an investigational device within 4 weeks prior to the first dose of study intervention.
* Participants with uncontrolled diabetes. Participants with controlled diabetes are allowed (insulin is allowed). HbA1c\>9.9% at screening are excluded.

Primary outcomes:
measure: Frequency of clinically significant laboratory abnormalities
timeFrame: Day 38
measure: Frequency of clinically significant vital signs
timeFrame: Day 38
measure: Frequency of clinically significant ECGs
timeFrame: Day 38
Secondary outcomes:
measure: Nimacimab serum concentration
timeFrame: Day 3, Day 8, Day 10, Day 38
Other outcomes:
measure: Measure rate of gastric emptying after ingestion of a radio-labeled meal as measured by gamma scans (scintigraphy) at 0, 0.5, 1, 2, 3, and 4 hours post meal
timeFrame: Baseline, Day 10
measure: Gastric emptying half-time as measured by gamma scans (scintigraphy) after ingestion of a radio-labeled meal.
timeFrame: Baseline, Day 10
measure: Change from baseline in American Neurogastroenterology and Motility Society Gastroparesis Cardinal Symptom Index Daily Diary (GCSI-DD) Composite Score at 15 days
timeFrame: Baseline and 15 days
Locations:
city: Miami
country: United States
facility: Panax Clinical Research
state: Florida
city: Miami
country: United States
facility: International Research Associates, LLC
state: Florida
city: Wichita
country: United States
facility: PRN of Kansas
state: Kansas
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
city: Chattanooga
country: United States
facility: ClinSearch
state: Tennessee
Study officials:
References: