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

NCT04451811 | Completed Phase 1 FDA Drug

• 1 other identifier: OPL-002-102
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

• AUC of OPL-002

  0 to 48 hours

Secondary Outcomes (2)

• Dose proportionality of 5 and 20 mg

  0 to 48 hours

• Absolute lymphocyte count

  0 to 48 hours

Study Arms (3)

OPL-002 SDD 20 mg

EXPERIMENTAL

20 mg SDD formulation of OPL-002

Drug: OPL-002

OPL-002 5 mg Tablet

EXPERIMENTAL

5 mg tablet formulation of OPL-002

Drug: OPL-002

OPL-002 20 mg Tablet

EXPERIMENTAL

20 mg tablet formulation of OPL-002

Drug: OPL-002

Interventions

OPL-002 DRUG

Spray dried dispersion and tablet formulation

OPL-002 20 mg Tablet; OPL-002 5 mg Tablet; OPL-002 SDD 20 mg

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Oppilan Pharma Ltd: lead
• Celerion: collaborator

Study Sites (1)

Celerion

Belfast, Northern Ireland, BT9 6AD, United Kingdom

Location

Study Officials

• Richard Gregg, MD

  Oppilan Pharma Ltd

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 25, 2020
• First Posted: June 30, 2020
• Study Start: September 7, 2020
• Primary Completion: February 24, 2021
• Study Completion: February 24, 2021
• Last Updated: May 28, 2021

Record last verified: 2020-09

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)