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

Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05409027
• Other study ID #: SPI-62-CL-1001
• Status: Completed
• Phase: Phase 1
• Start date: July 23, 2021
• Est. completion date: February 7, 2024

Study information

• Verified date: April 2024
• Source: Sparrow Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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)

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: February 7, 2024
• Est. primary completion date: March 10, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Obesity
• Type 2 Diabetes Mellitus in Obese

Intervention

Drug:
• SPI-62
SPI-62 is supplied as 1 mg tablets for oral dosing.
• Cortisone-d8
Cortisone-d8 is supplied as a 1 mcg/mL solution for infusion

Locations

Country	Name	City	State
United States	ProSciento	Chula Vista	California

Sponsors (1)

Lead Sponsor	Collaborator
Sparrow Pharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pharmacokinetics (Cmax)	Pharmacokinetics of SPI-62 and its major metabolite AS2570469 by assessment of Observed Maximum Plasma Concentration (Cmax)	Days 1 through 14
Secondary	Pharmacokinetics (tmax)	Pharmacokinetics of SPI-62 and its major metabolite AS2570469 by assessment of Time to Cmax (tmax)	Days 1 through 14
Secondary	Pharmacokinetics (AUC0-t)	Pharmacokinetics of SPI-62 and its major metabolite AS2570469 by assessment of Area Under the Curve over the dosing interval	Days 1 through 14
Secondary	Cortisone-d8 concentrations	individual values	Days 1 through 14
Secondary	Urinary HSD-1 Ratio	Individual values of the urinary HSD-1 ratio defined as (tetrahydrocortisol + allotetrahydrocortisol) / tetrahydrocortisone	Days -1 to 15