Clinical trial NCT05409027: A Study to Assess 11 Beta-hydroxysteroid Dehydrogenase Type 1 Inhibition in Adipose Tissue by SPI-62
Official title: A Study to Assess 11 Beta-hydroxysteroid Dehydrogenase Type 1 Inhibition in Adipose Tissue by SPI-62
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Type 2 Diabetes Mellitus in Obese
Obesity
Type2Diabetes
Lead sponsor: Sparrow Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2022-06-07
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

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.

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.

Primary outcomes:
measure: Pharmacokinetics (Cmax)
timeFrame: Days 1 through 14
Secondary outcomes:
measure: Pharmacokinetics (tmax)
timeFrame: Days 1 through 14
measure: Pharmacokinetics (AUC0-t)
timeFrame: Days 1 through 14
measure: Cortisone-d8 concentrations
timeFrame: Days 1 through 14
measure: Urinary HSD-1 Ratio
timeFrame: Days -1 to 15
Other outcomes:
Locations:
city: Chula Vista
country: United States
facility: ProSciento
state: California
Study officials:
affiliation: Sparrow Pharmaceuticals
name: David Katz, PhD
role: STUDY_DIRECTOR
References: