Migraine
Conditions
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.
Interventions
DRUGXC101-D13H
XC101-D13H supplied as 0.4, 0.8, 1.6 or 3.2 mg dose, administered in capsules
DRUGPlacebo
Placebo supplied as matching capsules
Sponsors
Xoc Pharmaceuticals
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
Double-blind
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
Inclusion 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Maximum plasma concentration [Cmax] of XC101-D13H | 48 hours | 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. |
| Area under the curve [AUC] of XC101-D13H | 48 hours | 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. |
| Time to reach maximum plasma concentration [Tmax] of XC101-D13H | 48 hours | 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. |
Countries
United States
Outcome results
None listed