Single Ascending Dose Study Investigating the Safety, Tolerability, and PK of XC130-A10H in Healthy Adult Subjects
- Registration Number
- NCT04043338
- Lead Sponsor
- Xoc Pharmaceuticals
- 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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 56
- 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
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description XC130-A10H XC130-A10H XC130-A10H (single dose) Placebo Placebo placebo (single dose)
- Primary Outcome Measures
Name Time Method Incidence and severity of Adverse Events pre-dose through 14 days post-dose Adverse Events will be monitored throughout confinement in the clinic and through the 14-day follow-up visit.
Changes from baseline in systolic and diastolic blood pressure pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 48 hours Blood pressure (systolic and diastolic) will be measured pre-dose and throughout the study at the time points specified and compared to baseline.
- Secondary Outcome Measures
Name Time Method Area under the curve [AUC] of XC130-A10H 48 hours 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.
Time to reach the maximum plasma concentration [Tmax] of XC130-A10H 48 hours 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.
Maximum plasma concentration [Cmax] of XC13-A10H 48 hours 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.
Trial Locations
- Locations (1)
Celerion
🇺🇸Tempe, Arizona, United States