Clinical trial NCT04104399: Single Ascending Dose Study to Investigate the Safety and Pharmacokinetics of XC101-D13H in Healthy Adult Subjects
Official title: 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Migraine
Lead sponsor: Xoc Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2019-09-26
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Incidence and Severity of Adverse Events
timeFrame: pre-dose through 14 days post-dose
Secondary outcomes:
measure: Maximum plasma concentration [Cmax] of XC101-D13H
timeFrame: 48 hours
measure: Area under the curve [AUC] of XC101-D13H
timeFrame: 48 hours
measure: Time to reach maximum plasma concentration [Tmax] of XC101-D13H
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: