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

NCT ID: NCT04451811

Last Updated: 2021-05-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-09-07
• Study Completion Date: 2021-02-24

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

OPL-002 SDD 20 mg

20 mg SDD formulation of OPL-002

Group Type: EXPERIMENTAL

OPL-002

Intervention Type: DRUG

Spray dried dispersion and tablet formulation

OPL-002 5 mg Tablet

5 mg tablet formulation of OPL-002

Group Type: EXPERIMENTAL

OPL-002

Intervention Type: DRUG

Spray dried dispersion and tablet formulation

OPL-002 20 mg Tablet

20 mg tablet formulation of OPL-002

Group Type: EXPERIMENTAL

OPL-002

Intervention Type: DRUG

Spray dried dispersion and tablet formulation

Interventions

OPL-002

Spray dried dispersion and tablet formulation

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Celerion

INDUSTRY

Sponsor Role: collaborator

Oppilan Pharma Ltd

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Richard Gregg, MD

Role: STUDY_DIRECTOR

Oppilan Pharma Ltd

Locations

Celerion

Belfast, Northern Ireland, United Kingdom

Countries

United Kingdom

Other Identifiers

OPL-002-102

Identifier Type: -

Identifier Source: org_study_id