Single Ascending Dose Study Investigating the Safety, Tolerability, and PK of XC130-A10H in Healthy Adult Subjects

A Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Single Ascending Dose Study Investigating the Safety, Tolerability, and Pharmacokinetics of XC130-A10H in Healthy Adult Subjects

This is a randomized, double-blind, placebo-controlled, parallel-group single ascending dose (SAD) study. Up to 5 cohorts of 8 subjects (6 active and 2 placebo) are planned for evaluation. In each cohort, subjects will receive a single oral dose of XC130-A10H or matching placebo on Day 1. Safety, tolerability, and pharmacokinetics will be assessed throughout the study. Dose escalation will not take place until the Principal Investigator, Sponsor, and Medical Monitor have determined that adequate safety and tolerability from the previous cohorts have been demonstrated to permit proceeding to the next cohort.

Study Overview

• Status: Active, not recruiting
• Conditions: Parkinson's Disease
• Intervention / Treatment: Drug: XC130-A10H; Drug: Placebo

Detailed Description

This is a randomized, double-blind, placebo-controlled, parallel group SAD study conducted at one study center. Up to 5 cohorts of 8 subjects (6 active and 2 placebo) are planned for evaluation. In each cohort, subjects will receive a single oral dose of XC130-A10H or matching placebo on Day 1. Dose escalation will not take place until the Principal Investigator, Sponsor, and Medical Monitor have determined that adequate safety and tolerability from the previous cohorts have been demonstrated to permit proceeding to the next cohort.

Safety (i.e., adverse events [AEs], physical examinations, pulse oximetry, vital signs, orthostatic vital signs, 12-lead electrocardiograms (ECGs), clinical laboratory tests, Columbia suicide severity rating scale [C-SSRS], and Mini-Mental State Examination [MMSE]) will be assessed throughout the study. Blood samples will be collected through 48 hours post-dose for the PK assessment of XC130-A10H and the metabolites.

• Study Type: Interventional
• Enrollment (Anticipated): 56
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Tempe, Arizona, United States, 85283
      • Celerion

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 71 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Major Inclusion Criteria:

• Healthy, adult, male or female of non-childbearing potential only, 18-75 years of age.
• Body mass index (BMI) ≥ 18 and ≤ 32.0 kg/m2 at screening.
• Medically healthy with no clinically significant findings from medical history, physical examination, laboratory profiles, vital signs or ECGs.
• Understands the study procedures in the informed consent form (ICF), and is willing and able to comply with the protocol.

Major Exclusion Criteria:

• Mental or legal incapacitation or significant emotional problems either present at the time of the screening visit or expected during the conduct of the study.
• History or presence of clinically significant medical, surgical or psychiatric condition or disease.
• History of any illness that, in the opinion of the PI, might confound the results of the study or poses an additional risk to the subject by their participation in the study.
• History of clinically significant hypotension.
• History of orthostatic hypotension in the 12 months prior to screening.
• Clinically significant hypertension at screening.
• History or presence of alcoholism within the 2 years prior to dosing or any history of drug abuse.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: XC130-A10H; XC130-A10H (single dose)	Drug: XC130-A10H; XC130-A10H supplied as a 0.2, 0.4, 0.8, 1.6 or 3.2 mg dose, administered in capsules or tablets
Placebo Comparator: Placebo; placebo (single dose)	Drug: Placebo; Placebo supplied as matching capsules or tablets

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence and severity of Adverse Events	Adverse Events will be monitored throughout confinement in the clinic and through the 14-day follow-up visit.	pre-dose through 14 days post-dose
Changes from baseline in systolic and diastolic blood pressure	Blood pressure (systolic and diastolic) will be measured pre-dose and throughout the study at the time points specified and compared to baseline.	pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 48 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Maximum plasma concentration [Cmax] of XC13-A10H	Blood samples will be collected pre-dose, 0.5, 1, 1.5, 2, 3, 4, 8, 12, 18, 24, and 48 hours post-dose and the maximum observed concentration for XC130-A10H and primary metabolite will be calculated.	48 hours
Area under the curve [AUC] of XC130-A10H	Blood samples will be collected pre-dose, 0.5, 1, 1.5, 2, 3, 4, 8, 12, 18, 24, and 48 hours post-dose and the area under the concentration-time curve, from time 0 to the last observed non-zero concentration will be calculated for XC130-A10H and primary metabolite.	48 hours
Time to reach the maximum plasma concentration [Tmax] of XC130-A10H	Blood samples will be collected pre-dose, 0.5, 1, 1.5, 2, 3, 4, 8, 12, 18, 24, and 48 hours post-dose and the time to reach the maximum plasma concentration of XC130-A10H and primary metabolite will be calculated.	48 hours

Collaborators and Investigators

• Sponsor: Xoc Pharmaceuticals
• Collaborators: Celerion
• Investigators: Study Director: Robert Fishman, MD, Xoc Consulting Chief Medical Officer

Study record dates

Study Major Dates

• Study Start (Actual): August 11, 2019
• Primary Completion (Anticipated): January 30, 2022
• Study Completion (Anticipated): April 30, 2022

Study Registration Dates

• First Submitted: July 24, 2019
• First Submitted That Met QC Criteria: July 31, 2019
• First Posted (Actual): August 2, 2019

Study Record Updates

• Last Update Posted (Actual): September 23, 2021
• Last Update Submitted That Met QC Criteria: September 16, 2021
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Parkinsonian Disorders; Basal Ganglia Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Parkinson Disease
• Other Study ID Numbers: XC130-A10H-CL-101

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No