A Study to Assess 11 Beta-hydroxysteroid Dehydrogenase Type 1 Inhibition in Adipose Tissue by SPI-62

NCT ID: NCT05409027

Last Updated: 2024-04-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-07-23
• Study Completion Date: 2024-02-07

Brief Summary

This will be an exploratory, open-label study of 11β-hydroxysteroid dehydrogenase type 1 (HSD-1) inhibition by SPI-62 in obese subjects with type 2 diabetes mellitus (T2DM)

Detailed Description

The main objective of the study is to characterize the relationship between SPI-62 plasma concentration and adipose tissue inhibition of HSD-1 in obese subjects with T2DM.Additional objectives of the study are to characterize the relationship between adipose SPI-62 concentration and HSD-1 inhibition, to characterize the relationship between SPI-62 plasma concentration and liver inhibition of HSD-1, and to monitor the safety and tolerability of SPI-62, in obese subjects with T2DM. This will be a Phase I, open-label study in male and non-menstruating female subjects. Potential subjects will be screened to assess their eligibility to enter the study within 28 days prior to the first dose administration. Subjects will receive SPI-62 daily for up to 14 days. Subjects will also receive cortisone-d8, a mass-labeled HSD-1 substrate, by infusion during one or two confined study visits during the period of SPI-62 administration. Subjects may also receive cortisone-d8 during one to four additional confined study visits after cessation of SPI-62. Subjects will receive a follow-up call approximately 30 days after the last dose of study drug (SPI-62 or cortisone-d8). Results of population pharmacokinetic-pharmacodynamic modeling of data from this trial combined with those of prior trials will be reported separately from the Clinical Study Report.

Conditions

Type 2 Diabetes Mellitus in Obese; Obesity; Type2Diabetes

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

Single Arm

Each subject will receive between 1 to 15 mg SPI-62 QD PO for up to 14 days.

Each subject will receive up to 12 mcg cortisone-d8 SC during each of one or more study visits.

Group Type: EXPERIMENTAL

SPI-62

Intervention Type: DRUG

SPI-62 is supplied as 1 mg tablets for oral dosing.

Cortisone-d8

Intervention Type: DRUG

Cortisone-d8 is supplied as a 1 mcg/mL solution for infusion

Interventions

SPI-62

SPI-62 is supplied as 1 mg tablets for oral dosing.

Intervention Type: DRUG

Cortisone-d8

Cortisone-d8 is supplied as a 1 mcg/mL solution for infusion

Intervention Type: DRUG

Other Intervention Names

HSD-1 inhibitor; Glucocorticoid and anti-inflammatory agent

Eligibility Criteria

Inclusion Criteria

• Male or non-menstruating female
• 18 to 65 years of age
• BMI 30.0 to 45.0 kg/m2
• Diagnosis of T2DM for at least 3 months prior to the first dose of study drug.

Exclusion Criteria

• Uncontrolled T2DM with glycated hemoglobin ≥9.5%.
• Any other current or prior medical condition expected to interfere with the conduct of the trial or the evaluation of its results.
• Any clinically significant abnormal laboratory value which cannot be explained by a known and permitted clinical condition.
• Positive urine drug screen (except tetrahydrocannabinol) or positive alcohol breath test result.
• Participation in a clinical trial involving administration of an investigational drug (new chemical entity) in the past 30 days or 5 half-lives, whichever is longer, or 90 days for a biological, prior to the first dose of study drug.
• Use of, or intent to use, any medications/products (prescription or over-the-counter) or herbal supplements within 4 weeks prior to the first dose of study drug, except those specifically allowed in the protocol.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Sparrow Pharmaceuticals

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

David Katz, PhD

Role: STUDY_DIRECTOR

Sparrow Pharmaceuticals

Locations

ProSciento

Chula Vista, California, United States

Countries

United States

Other Identifiers

SPI-62-CL-1001

Identifier Type: -

Identifier Source: org_study_id