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

• ClinicalTrials.gov Identifier: NCT03900325
• Recruitment Status: Unknown
• First Posted: April 3, 2019
• Last Update Posted: January 18, 2020
• Sponsor: Bird Rock Bio, Inc.
• Information provided by (Responsible Party): Bird Rock Bio, Inc.

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Diabetic Gastroparesis	Drug: Nimacimab; Drug: Placebo	Phase 2

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 6 participants
• Allocation: Non-Randomized
• Intervention Model: Sequential Assignment
• Masking: Single (Participant)
• Primary Purpose: Treatment
• Official Title: A Single-Blind Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Exploratory Efficacy of Nimacimab in Patients With Diabetic Gastroparesis
• Actual Study Start Date: August 1, 2019
• Estimated Primary Completion Date: January 2020
• Estimated Study Completion Date: April 2020

Arms and Interventions

Arm	Intervention/treatment
Experimental: Nimacimab; 2.5 mg/kg	Drug: Nimacimab; 2.5 mg/kg
Placebo Comparator: Placebo; 0.9% sodium chloride	Drug: Placebo; 0.9% sodium chloride

Outcome Measures

Primary Outcome Measures :

1. Frequency of clinically significant laboratory abnormalities [ Time Frame: Day 38 ]
2. Frequency of clinically significant vital signs [ Time Frame: Day 38 ]
3. Frequency of clinically significant ECGs [ Time Frame: Day 38 ]

Secondary Outcome Measures :

1. Nimacimab serum concentration [ Time Frame: Day 3, Day 8, Day 10, Day 38 ]
   Area under the plasma concentration versus time curve (AUC)

Other Outcome Measures:

1. 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 [ Time Frame: Baseline, Day 10 ]
2. Gastric emptying half-time as measured by gamma scans (scintigraphy) after ingestion of a radio-labeled meal. [ Time Frame: Baseline, Day 10 ]
   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.
3. Change from baseline in American Neurogastroenterology and Motility Society Gastroparesis Cardinal Symptom Index Daily Diary (GCSI-DD) Composite Score at 15 days [ Time Frame: Baseline and 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).

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 70 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

United States, Florida

Panax Clinical Research

Miami, Florida, United States, 33014

International Research Associates, LLC

Miami, Florida, United States, 33183

United States, Kansas

PRN of Kansas

Wichita, Kansas, United States, 67205

United States, Minnesota

Mayo Clinic

Rochester, Minnesota, United States, 55905

United States, Tennessee

ClinSearch

Chattanooga, Tennessee, United States, 37421

Sponsors and Collaborators

Bird Rock Bio, Inc.

More Information

• Responsible Party: Bird Rock Bio, Inc.
• ClinicalTrials.gov Identifier: NCT03900325
• Other Study ID Numbers: BRB-018-200DG
• First Posted: April 3, 2019
• Last Update Posted: January 18, 2020
• Last Verified: August 2019

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Gastroparesis; Stomach Diseases; Gastrointestinal Diseases; Digestive System Diseases; Paralysis; Neurologic Manifestations