Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Exploratory Efficacy of Nimacimab in Patients With Diabetic Gastroparesis

Diabetic Gastroparesis Clinical Trial

Official title:

A Single-Blind Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Exploratory Efficacy of Nimacimab in Patients With Diabetic Gastroparesis

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03900325
• Other study ID #: BRB-018-200DG
• Status: Active, not recruiting
• Phase: Phase 2
• Start date: August 1, 2019
• Est. completion date: April 2020

Study information

• Verified date: August 2019
• Source: Bird Rock Bio, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 6
• Est. completion date: April 2020
• Est. primary completion date: January 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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• Participants on prokinetic therapy should have these medications withdrawn at least 7 days prior to any study scintigraphy exam and at least 7 days prior to the first dose through Day 15 of treatment.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.

Related Conditions & MeSH terms

• Diabetic Gastroparesis
• Gastroparesis

Intervention

Drug:
• Nimacimab
2.5 mg/kg
• Placebo
0.9% sodium chloride

Locations

Country	Name	City	State
United States	ClinSearch	Chattanooga	Tennessee
United States	International Research Associates, LLC	Miami	Florida
United States	Panax Clinical Research	Miami	Florida
United States	Mayo Clinic	Rochester	Minnesota
United States	PRN of Kansas	Wichita	Kansas

Sponsors (1)

Lead Sponsor	Collaborator
Bird Rock Bio, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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		Baseline, Day 10
Other	Gastric emptying half-time as measured by gamma scans (scintigraphy) after ingestion of a radio-labeled meal.	Half time (t1/2) of gastric emptying (GE) of solids is the time for half of the ingested solids or liquids to leave the stomach.	Baseline, Day 10
Other	Change from baseline in American Neurogastroenterology and Motility Society Gastroparesis Cardinal Symptom Index Daily Diary (GCSI-DD) Composite Score at 15 days	The ANMS GCSI-DD composite score includes score of nausea, early satiety, upper abdominal pain and postprandial fullness. The severity scores of these symptoms range from 0 ( none) to 4 (very severe).	Baseline and 15 days
Primary	Frequency of clinically significant laboratory abnormalities		Day 38
Primary	Frequency of clinically significant vital signs		Day 38
Primary	Frequency of clinically significant ECGs		Day 38
Secondary	Nimacimab serum concentration	Area under the plasma concentration versus time curve (AUC)	Day 3, Day 8, Day 10, Day 38