Safety, Tolerability, and Pharmacodynamics of NOV-001 in Adult Subjects

Overview

About this study

The purpose of the first stage of this study is to evaluate safety, tolerability, and pharmacodynamics of NOV-001 in adult healthy volunteers.  The purpose of the second stage of this study is to evaluate safety, tolerability, and early effectiveness in patients with enteric hyperoxaluria.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Stage 1 Key Inclusion Criteria:

- Ages 18 to 55

- Body mass index (BMI) < 38 kg/m2.

- Healthy as defined by no clinically relevant abnormalities being identified by a
detailed medical history, physical examination, and clinical laboratory tests.

- If woman of child-bearing potential, must not be pregnant, and must also agree to use
an appropriate highly-effective contraceptive.

- Willing and able to comply with all study requirements, including duration of stay at
inpatient unit, dietary restrictions, daily study product administration, pregnancy
testing and contraception (if applicable), stool collections, and blood and urine
collections.

Stage 1 Key Exclusion Criteria:

- Estimated glomerular filtration rate (eGFR) < 80 mL/min/1.73 m2 at Screening.

- Oral or parenteral antibiotics within 4 weeks prior to Screening, or anticipation of
the need for such antibiotics during the Screening or treatment periods of the study.

- Current or history of any clinically significant medical illness or disorder the
Investigator considers should exclude the subject from the study.

- Participation in any investigational intervention study within 30 days prior to study
product administration in this study.

- Known hypersensitivity to omeprazole.

- Applicable only to certain study groups depending on emerging Stage 1 data: no current
or anticipated use during the screening or treatment periods of the study of
medications that have the potential for drug-drug interactions (DDI) with omeprazole.

Stage 2 Key Inclusion Criteria:

- Ages 18 to 65.

- Hyperoxaluria secondary to Roux-en-Y gastric bypass surgery or to biliopancreatic
diversion with duodenal switch (BPD-DS) surgery.

- 24-Hour urinary oxalate (UOx) ≥ 60 mg.

- If woman of child-bearing potential, must not be pregnant and must also agree to use
an appropriate highly effective contraceptive method.

- Must, in the opinion of the Investigator, be in otherwise good health.

- Willing and able to comply with all study requirements, including dietary
restrictions, daily study product administration, pregnancy testing and contraception
(if applicable), stool collections, and blood and 24-hour urine collections.

Stage 2 Key Exclusion Criteria:

- Chronic kidney disease with eGFR < 30 mL/min/1.73 m2 at Screening.

- Evidence of current acute renal injury or ongoing clinically significant renal
disease.

- Oral or parenteral antibiotics within 4 weeks prior to Screening, or anticipation of
the need for such antibiotics during the Screening or treatment periods of the study
(topical antibiotics are permissible.)

- Taking during the study any treatment for hyperoxaluria except for NOV-001, other than
stable treatments for the management of kidney stones.

- Taking Vitamin C ≥ 300 mg/day for > 10 days within 7 days prior to Screening;
unwilling or unable to discontinue and/or avoid Vitamin C supplementation for the
duration of study product treatment.

- Known active autoimmune disorder or other condition requiring high dose of systemic
corticosteroids (i.e., > 10 mg/day prednisone or equivalent) or other
immunosuppressant therapy.

- Current or history of any clinically significant medical illness or disorder other
than enteric hyperoxaluria that the Investigator considers should exclude the patient
from the study.

- Participation in any investigational intervention study within 30 days prior to study
product administration in this study.

- Known hypersensitivity to omeprazole.

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Eligibility last updated 9/15/22. Questions regarding updates should be directed to the study team contact.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

John Lieske, M.D.

Open for enrollment

Contact information:

Carly Banks CCRP

(507) 255-4347

Banks.Carly@mayo.edu

More information

Publications

Publications are currently not available
.

Mayo Clinic Footer