A Phase 1, Open-Label, Randomized, Crossover Study to Evaluate the Effect of Food on the Pharmacokinetics of SLC-391 in Healthy Adult Subjects

SignalChem Lifesciences Corporation1 site in 1 country22 target enrollmentFebruary 12, 2022

ConditionsFood-drug Interaction

InterventionsSLC-391

DrugsSLC-391

Overview

Phase: Phase 1
Intervention: SLC-391
Conditions: Food-drug Interaction
Sponsor: SignalChem Lifesciences Corporation
Enrollment: 22
Locations: 1
Primary Endpoint: Maximum Observed Plasma Concentration (Cmax)
Status: Completed
Last Updated: 3 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

This will be a single center, Phase 1, open-label, randomized, single dose, 2-period, 2-sequence, crossover study to evaluate the PK, safety, and tolerability of a single oral dose of SLC-391 under fed and fasted conditions in approximately 22 healthy male and non-childbearing potential female subjects.

Subjects will be randomized in a 1:1 ratio to one of two treatment sequences with 11 subjects per treatment sequence. Each subject will receive both treatments (Treatment A and Treatment B) with a washout period of at least 7 days between successive SLC-391.

Registry

clinicaltrials.gov

Start Date

February 12, 2022

End Date

June 14, 2022

Last Updated

3 years ago

Study Type

Interventional

Study Design

Crossover

Sex

All

Investigators

Sponsor

SignalChem Lifesciences Corporation

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Evidence of a personally signed and dated informed consent document indicating that the subject has been informed of all pertinent aspects of the study.
•Male or non-childbearing potential female, non-smoker (no use of tobacco or nicotine products within 3 months prior to screening, confirmed by cotinine test), ≥18 and ≤55 years of age, with body mass index (BMI) \>18.5 and \<30 kg/m2 and body weight ≥50.0 kg for males and ≥45.0 kg for females.
•Healthy as defined by:
•The absence of clinically significant illness and/or surgery within 4 weeks prior to dosing.
•The absence of clinically significant history of neurological, endocrine, cardiovascular, respiratory, hematological, immunological, psychiatric, gastrointestinal, renal, hepatic, and metabolic disease.
•Non-childbearing potential female defined as:
•Post-menopausal (spontaneous amenorrhea for at least 12 months prior to dosing) with confirmation by documented follicle stimulating hormone (FSH) levels ≥ 40 mIU/mL; or
•Surgically sterile (bilateral oophorectomy, hysterectomy or tubal ligation at least 3 months prior to dosing, verified through medical records). If surgical sterility cannot be verified, female subjects who are sexually active with a non-sterile male partner (sterile male partners are defined as men vasectomized for at least 3 months prior to dosing) must be willing to use one of the following acceptable contraceptive methods throughout the study and for 90 days after the last dose:
•(i) Simultaneous use of hormonal contraceptive (e.g., oral, patch, depot injection, implant, vaginal ring, intrauterine device) or non-hormonal intrauterine device used for at least 4 weeks prior to dosing (must agree to use the same contraceptive throughout the study) and condom for the male partner; (ii) Simultaneous use of diaphragm or cervical cap with spermicide and condom for the male partner, started at least 21 days prior to dosing.
•Male subjects who are sexually active with a female partner of childbearing potential (childbearing potential females are defined as women that are neither post-menopausal nor surgically sterile) must be willing to use one of the following acceptable contraceptive methods from the first dose and for 90 days after the last dose, unless they can provide medical records indicating that they have been vasectomized for at least 3 months prior to dosing:

Exclusion Criteria

•Any clinically significant abnormality at physical examination, clinically significant abnormal laboratory test results or positive test for human immunodeficiency virus (HIV) antigen, hepatitis B surface antigen (HBsAg), or hepatitis C virus (HCV) antibody found during medical screening.
•Positive urine drug screen, alcohol breath test or urine cotinine test at screening.
•History of allergic reactions to SLC-391 or to any excipient in the formulation.
•History of clinically significant allergy or hypersensitivity to any drug or food or other substance.
•History of lactose or galactose intolerance, lactase deficiency, or glucose-galactose malabsorption.
•Positive pregnancy test at screening or breastfeeding subject.
•Male subjects with partners that are currently pregnant or planning to become pregnant during the study or within 30 days following the last dose of the study drug.
•Clinically significant ECG abnormalities (Fridericia's corrected QT interval \[QTcF\] ≥450 msec) or vital sign abnormalities (systolic blood pressure \[BP\] lower than 90 or over 140 mmHg, diastolic BP lower than 50 or over 90 mmHg, heart rate \[HR\] less than 50 or over 100 beats per minute \[bpm\]), or respiratory rate (RR) less than 8 or over 20 respirations per minute (rpm) at screening.
•History of or a family history of congenital QT prolongation or with a history of risk factors for torsade de pointes (e.g., heart failure, hypokalemia, family history of long QT Syndrome), or use of concomitant medications that prolong the QT/ QT interval corrected for HR (QTc interval).
•History or presence of sustained or symptomatic bradycardia (≤40 bpm), left bundle branch block, ventricular arrhythmia excluding premature ventricular contractions (PVCs) or uncontrolled ventricular arrhythmia. Subjects with a supraventricular arrhythmia not requiring medical treatment and a normal ventricular rate are eligible.

Arms & Interventions

Treatment Sequence 1

SLC-391 10 mg capsules (manufactured by China Gateway Pharmaceutical Development Co. (Shanghai, P.R. China)) administered as 5 x 10 mg capsules under fasted conditions.

Intervention: SLC-391

Treatment Sequence 2

SLC SLC-391 10 mg capsules (manufactured by China Gateway Pharmaceutical Development Co. (Shanghai, P.R. China)) administered as 5 x 10 mg capsules under fed conditions.

Intervention: SLC-391

Outcomes

Primary Outcomes

Maximum Observed Plasma Concentration (Cmax)

Time Frame: 14 days

Cmax is the maximum observed plasma concentration in ng/mL

Area under the plasma concentration versus time curve (AUC) of SLC-391

Time Frame: 14 days

Changes in AUC (AUC0-t and AUC0-inf) over time in subjects taking SLC-391 capsules administered as a single oral 50 mg dose under fasted and fed conditions in healthy adult subjects.

Secondary Outcomes

Number of Participants with Clinically Significant Changes From Baseline in physical examinations(14 days)
Pharmacokinetic (PK) parameters calculated for SLC-391 in plasma concentrations: Kel.(14 days)
Pharmacokinetic (PK) parameters calculated for SLC-391 in plasma concentrations: MRT.(14 days)
Number of Participants with Treatment-emergent Adverse Events (TEAEs) as assessed by NCI-CTCAE v5.0(35 days)
Number of Participants with Serious Adverse Events (SAEs) as assessed by NCI-CTCAE v5.0(35 days)
Pharmacokinetic (PK) parameters calculated for SLC-391 in plasma concentrations: Tmax.(14 days)
Pharmacokinetic (PK) parameters calculated for SLC-391 in plasma concentrations: T½ el.(14 days)
Pharmacokinetic (PK) parameters calculated for SLC-391 in plasma concentrations: Vd/F.(14 days)
Pharmacokinetic (PK) parameters calculated for SLC-391 in plasma concentrations: Cl/F.(14 days)
Number of Participants with Clinically Significant Changes From Baseline in Laboratory Parameters(14 days)
Number of Participants with Clinically Significant Changes From Baseline in electrocardiogram (ECGs) Findings(14 days)
Number of Participants with Clinically Significant Changes From Baseline in Vital Signs(14 days)