A PK Dose Proportionality Study of OPL-002 in Healthy Volunteers

Study Overview
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Brief Summary
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This is a single center, randomized, open-label, three-way crossover, single dose, pharmacokinetic dose proportionality study of oral OPL-002 in healthy subjects.

Official Title
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A Pharmacokinetic Dose Proportionality Study of OPL-002 in Healthy Volunteers

Conditions
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Healthy

Intervention / Treatment
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* Drug: OPL-002


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or female (of non-childbearing potential only) between 18 and 55 years of age. Females must be of non-childbearing potential and must have undergone one of the following sterilization procedures, and have official documentation, at least 6 months prior to the first dose: hysteroscopic sterilization; bilateral tubal ligation or bilateral salpingectomy; hysterectomy; bilateral oophorectomy, or; be postmenopausal with amenorrhea for at least 1 year prior to the first dose and have FSH serum levels consistent with postmenopausal status as per investigator judgment. Male subjects must use reliable forms of contraception from screening to 30 days after the end of dosing. Good general health as determined by medical history, and by results of physical examination, vital signs, ECG, and clinical laboratory tests obtained within 28 days (4 weeks) prior to study drug administration. Exclusion Criteria: History or presence of any clinically significant organ system disease that could interfere with the objectives of the study or the safety of the subjects. pressure and heart rate are outside the ranges 90-140 mmHg systolic, 40-90 mmHg diastolic, heart rate 60-100 beats/min. 12-lead ECG with any abnormality judged by the Investigator to be clinically significant, QRS >= 110 milliseconds (msec), QT/QTcF interval of > 450 msec for men or >470 msec for women, or PR > 200 msec. Presence or history of any abnormality or illness, which in the opinion of the Investigator may affect absorption, distribution, metabolism or elimination of the study drug.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: OPL-002 SDD 20 mg<br>20 mg SDD formulation of OPL-002 | Drug: OPL-002<br>* Spray dried dispersion and tablet formulation<br>|
| Experimental: OPL-002 5 mg Tablet<br>5 mg tablet formulation of OPL-002 | Drug: OPL-002<br>* Spray dried dispersion and tablet formulation<br>|
| Experimental: OPL-002 20 mg Tablet<br>20 mg tablet formulation of OPL-002 | Drug: OPL-002<br>* Spray dried dispersion and tablet formulation<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| AUC of OPL-002 |  | 0 to 48 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Dose proportionality of 5 and 20 mg |  | 0 to 48 hours | 
| Absolute lymphocyte count |  | 0 to 48 hours |