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

NCT04104399 | Unknown Phase 1 FDA Drug

• 1 other identifier: XC101-D13H-CL-1
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Migraine

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Maximum plasma concentration [Cmax] of XC101-D13H

  48 hours

• Area under the curve [AUC] of XC101-D13H

  48 hours

• Time to reach maximum plasma concentration [Tmax] of XC101-D13H

  48 hours

Study Arms (2)

XC101-D13H

EXPERIMENTAL

single dose

Drug: XC101-D13H

Placebo

PLACEBO COMPARATOR

single dose

Drug: Placebo

Interventions

XC101-D13H DRUG

XC101-D13H supplied as 0.4, 0.8, 1.6 or 3.2 mg dose, administered in capsules

XC101-D13H

Placebo DRUG

Placebo supplied as matching capsules

Placebo

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Xoc Pharmaceuticals: lead

Study Sites (1)

Celerion

Tempe, Arizona, 85283, United States

Location

MeSH Terms

Conditions

Migraine Disorders

Condition Hierarchy (Ancestors)

Headache Disorders, Primary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Robert Fishman, MD

  Xoc Consulting Chief Medical Officer

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Double-blind
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 23, 2019
• First Posted: September 26, 2019
• Study Start: October 8, 2019
• Primary Completion: January 28, 2022
• Study Completion: March 30, 2022
• Last Updated: September 23, 2021

Record last verified: 2021-09

Locations

US (1)