Clinical trial NCT04043338: Single Ascending Dose Study Investigating the Safety, Tolerability, and PK of XC130-A10H in Healthy Adult Subjects
Official title: 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Parkinson's Disease
Lead sponsor: Xoc Pharmaceuticals
Sponsor class: INDUSTRY
Collaborators: name: Celerion
First posted: 2019-08-02
Enrollment: 56
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Incidence and severity of Adverse Events
timeFrame: pre-dose through 14 days post-dose
measure: Changes from baseline in systolic and diastolic blood pressure
timeFrame: pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 48 hours
Secondary outcomes:
measure: Maximum plasma concentration [Cmax] of XC13-A10H
timeFrame: 48 hours
measure: Area under the curve [AUC] of XC130-A10H
timeFrame: 48 hours
measure: Time to reach the maximum plasma concentration [Tmax] of XC130-A10H
timeFrame: 48 hours
Other outcomes:
Locations:
city: Tempe
country: United States
facility: Celerion
state: Arizona
Study officials:
affiliation: Xoc Consulting Chief Medical Officer
name: Robert Fishman, MD
role: STUDY_DIRECTOR
References: