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

Sponsor
Sparrow Pharmaceuticals (Industry)
Overall Status
Active, not recruiting
CT.gov ID
NCT05409027
Collaborator
(none)
12
1
1
11.1
1.1

Study Details

Study Description

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)

Condition or Disease Intervention/Treatment Phase
Phase 1

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
12 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Basic Science
Official Title:
A Study to Assess 11 Beta-hydroxysteroid Dehydrogenase Type 1 Inhibition in Adipose Tissue by SPI-62
Actual Study Start Date :
Aug 5, 2021
Actual Primary Completion Date :
Mar 7, 2022
Anticipated Study Completion Date :
Jul 8, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: 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.

Drug: SPI-62
SPI-62 is supplied as 1 mg tablets for oral dosing.
Other Names:
  • HSD-1 inhibitor
  • Drug: Cortisone-d8
    Cortisone-d8 is supplied as a 1 mcg/mL solution for infusion
    Other Names:
  • Glucocorticoid and anti-inflammatory agent
  • Outcome Measures

    Primary Outcome Measures

    1. Pharmacokinetics (Cmax) [Days 1 through 14]

      Pharmacokinetics of SPI-62 and its major metabolite AS2570469 by assessment of Observed Maximum Plasma Concentration (Cmax)

    Secondary Outcome Measures

    1. Pharmacokinetics (tmax) [Days 1 through 14]

      Pharmacokinetics of SPI-62 and its major metabolite AS2570469 by assessment of Time to Cmax (tmax)

    2. Pharmacokinetics (AUC0-t) [Days 1 through 14]

      Pharmacokinetics of SPI-62 and its major metabolite AS2570469 by assessment of Area Under the Curve over the dosing interval

    3. Cortisone-d8 concentrations [Days 1 through 14]

      individual values

    4. Urinary HSD-1 Ratio [Days -1 to 15]

      Individual values of the urinary HSD-1 ratio defined as (tetrahydrocortisol + allotetrahydrocortisol) / tetrahydrocortisone

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 65 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Prociento San Diego California United States 92121

    Sponsors and Collaborators

    • Sparrow Pharmaceuticals

    Investigators

    • Study Director: David Katz, PhD, Sparrow Pharmaceuticals

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Sparrow Pharmaceuticals
    ClinicalTrials.gov Identifier:
    NCT05409027
    Other Study ID Numbers:
    • SPI-62-CL-1001
    First Posted:
    Jun 7, 2022
    Last Update Posted:
    Jun 7, 2022
    Last Verified:
    Jun 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    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 Jun 7, 2022