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

Sponsor
Bird Rock Bio, Inc. (Industry)
Overall Status
Unknown status
CT.gov ID
NCT03900325
Collaborator
(none)
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Study Details

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
Phase 2

Study Design

Study Type:
Interventional
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 :
Aug 1, 2019
Anticipated Primary Completion Date :
Jan 1, 2020
Anticipated Study Completion Date :
Apr 1, 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 [Day 38]

  2. Frequency of clinically significant vital signs [Day 38]

  3. Frequency of clinically significant ECGs [Day 38]

Secondary Outcome Measures

  1. Nimacimab serum concentration [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 [Baseline, Day 10]

  2. Gastric emptying half-time as measured by gamma scans (scintigraphy) after ingestion of a radio-labeled meal. [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 [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

Criteria

Ages Eligible for Study:
18 Years to 70 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Site City State Country Postal Code
1 Panax Clinical Research Miami Florida United States 33014
2 International Research Associates, LLC Miami Florida United States 33183
3 PRN of Kansas Wichita Kansas United States 67205
4 Mayo Clinic Rochester Minnesota United States 55905
5 ClinSearch Chattanooga Tennessee United States 37421

Sponsors and Collaborators

  • Bird Rock Bio, Inc.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Bird Rock Bio, Inc.
ClinicalTrials.gov Identifier:
NCT03900325
Other Study ID Numbers:
  • BRB-018-200DG
First Posted:
Apr 3, 2019
Last Update Posted:
Jan 18, 2020
Last Verified:
Aug 1, 2019
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jan 18, 2020