Single Ascending Dose Study to Investigate the Safety and Pharmacokinetics of XC101-D13H in Healthy Adult Subjects

A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Single Ascending Dose Study to Investigate the Safety, Tolerability, and Pharmacokinetics of XC101-D13H in Healthy Adult Subjects

This is a randomized, double-blind, placebo-controlled, parallel-group single ascending dose (SAD) study. There are 4 cohorts of 8 subjects (8 active and 2 placebo) planned for evaluation under fasting conditions. One of the planned dose levels will cross over after a washout period to receive the same single dose of XC101-D13H or placebo under fed conditions.

Study Overview

• Status: Active, not recruiting
• Conditions: Migraine
• Intervention / Treatment: Drug: XC101-D13H; Drug: Placebo

Detailed Description

This is a randomized, double-blind, placebo-controlled, parallel-group single ascending dose (SAD) study. There are 4 cohorts of 8 subjects (8 active and 2 placebo) planned for evaluation under fasting conditions. One of the planned dose levels will cross over after a washout period to receive the same single dose of XC101-D13H or placebo under fed conditions. Dose escalation will be supervised by a Safety Monitoring Board (SMB). Dose escalation to the next dose level will not take place until the SMB has determined that adequate safety, tolerability, PK, and core-lab analyzed ECGs from the previous cohort and all previous cohorts have been demonstrated to permit proceeding to the next cohort. PK data from all available cohorts will be used to guide the dose-escalation decisions.

• Study Type: Interventional
• Enrollment (Anticipated): 32
• 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: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Major Inclusion Criteria:

• Healthy, adult, male or female of non childbearing potential only, 18-55 years of age, inclusive, at screening.
• Body mass index (BMI) ≥ 18 and ≤ 30.0 kg/m2 at screening.
• Medically healthy with no clinically significant finding in medical history, physical examination, laboratory profiles, vital signs, or ECGs, as judged by the PI or designee. Creatinine must be within the upper limit of normal at screening.
• Understands the study procedures in the informed consent form (ICF), and is willing and able to comply with the protocol.

Major Exclusion Criteria:

• Is mentally or legally incapacitated or has significant emotional problems at the time of the screening visit or expected during the conduct of the study.
• History or presence of clinically significant medical, surgical, clinical laboratory, or psychiatric condition or disease.
• History of any illness that, in the opinion of the PI or designee, 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 lightheadedness, dizziness or syncope in the 12 months prior to screening.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo; single dose	Drug: Placebo; Placebo supplied as matching capsules
Experimental: XC101-D13H; single dose	Drug: XC101-D13H; XC101-D13H supplied as 0.4, 0.8, 1.6 or 3.2 mg dose, administered in capsules

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Maximum plasma concentration [Cmax] of XC101-D13H	Blood samples will be collected pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36, and 48 hours post-dose and the maximum observed concentration for XC101-D13H will be calculated.	48 hours
Area under the curve [AUC] of XC101-D13H	Blood samples will be collected pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36, 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 XC101-D13H.	48 hours
Time to reach maximum plasma concentration [Tmax] of XC101-D13H	Blood samples will be collected pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36, and 48 hours post-dose and the time to reach the maximum plasma concentration of XC101-D13H will be calculated.	48 hours

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): October 8, 2019
• Primary Completion (Anticipated): January 28, 2022
• Study Completion (Anticipated): March 30, 2022

Study Registration Dates

• First Submitted: September 23, 2019
• First Submitted That Met QC Criteria: September 24, 2019
• First Posted (Actual): September 26, 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

• Other Study ID Numbers: XC101-D13H-CL-1

Drug and device information, study documents

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