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

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

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

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: OPL-002

• Study Type: Interventional
• Enrollment (Actual): 12
• Phase: Phase 1

Contacts and Locations

Study Locations

• United Kingdom
  • Northern Ireland
    • Belfast, Northern Ireland, United Kingdom, BT9 6AD
      • Celerion

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 51 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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:

  1. hysteroscopic sterilization;
  2. bilateral tubal ligation or bilateral salpingectomy;
  3. hysterectomy;
  4. bilateral oophorectomy, or;
  5. 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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Oppilan Pharma Ltd
• Collaborators: Celerion
• Investigators: Study Director: Richard Gregg, MD, Oppilan Pharma Ltd

Study record dates

Study Major Dates

• Study Start (Actual): September 7, 2020
• Primary Completion (Actual): February 24, 2021
• Study Completion (Actual): February 24, 2021

Study Registration Dates

• First Submitted: June 25, 2020
• First Submitted That Met QC Criteria: June 25, 2020
• First Posted (Actual): June 30, 2020

Study Record Updates

• Last Update Posted (Actual): May 28, 2021
• Last Update Submitted That Met QC Criteria: May 26, 2021
• Last Verified: September 1, 2020

More Information

Terms related to this study

• Other Study ID Numbers: OPL-002-102

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

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