HealthyPhase 1NCT04451811
A PK Dose Proportionality Study of OPL-002 in Healthy Volunteers
A Phase 1 study testing OPL-002 in people with Healthy, run by Oppilan Pharma Ltd at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- OPL-002
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 7 Sep 2020to 24 Feb 2021
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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;
Show all 9Show fewer
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Healthy
- Being tested
- OPL-002
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OPL-002Drug
Spray dried dispersion and tablet formulation
| Study group | Role | What they receive |
|---|---|---|
| OPL-002 SDD 20 mg | Experimental | 20 mg SDD formulation of OPL-002 Receives: Drug: OPL-002 |
| OPL-002 5 mg Tablet | Experimental | 5 mg tablet formulation of OPL-002 Receives: Drug: OPL-002 |
| OPL-002 20 mg Tablet | Experimental | 20 mg tablet formulation of OPL-002 Receives: Drug: OPL-002 |
What is being measured
The primary outcome is the main question the study is designed to answer.
AUC of OPL-002
Measured: 0 to 48 hours
Secondary outcomes (2)
Dose proportionality of 5 and 20 mg
Measured: 0 to 48 hours
Absolute lymphocyte count
Measured: 0 to 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jun 2020
- Study start7 Sep 2020
- Primary completion24 Feb 2021
- Study completion24 Feb 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oppilan Pharma Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Celerion
- Responsible party
- Sponsor
- Investigators
- Richard Gregg, MD, Study director, Oppilan Pharma Ltd
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04451811
- Sponsor's protocol ID
- OPL-002-102
- Status last verified
- Sep 2020
- First submitted
- 25 Jun 2020
- Last updated
- 28 May 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pharmacokinetic Dose Proportionality Study of OPL-002 in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT04451811
- Acronym / sponsor ID
- OPL-002-102
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Oppilan Pharma LtdIndustry (pharma, biotech, devices)
- Collaborators
- Celerion
- Study start
- 7 Sep 2020 (actual)
- Primary completion
- 24 Feb 2021 (actual)
- Study completion
- 24 Feb 2021 (actual)
- First posted
- 30 Jun 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| OPL-002 SDD 20 mg | Experimental | Drug: OPL-00220 mg SDD formulation of OPL-002 |
| OPL-002 5 mg Tablet | Experimental | Drug: OPL-0025 mg tablet formulation of OPL-002 |
| OPL-002 20 mg Tablet | Experimental | Drug: OPL-00220 mg tablet formulation of OPL-002 |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- 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:
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OPL-002Spray dried dispersion and tablet formulation | Drug | OPL-002 20 mg Tablet, OPL-002 5 mg Tablet, OPL-002 SDD 20 mg |
Primary outcome
AUC of OPL-002
Time frame: 0 to 48 hours
2 secondary outcomes
Dose proportionality of 5 and 20 mg
Time frame: 0 to 48 hours
Absolute lymphocyte count
Time frame: 0 to 48 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 May 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Richard Gregg, MD study director
Oppilan Pharma Ltd
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing OPL-002 in people with Healthy, run by Oppilan Pharma Ltd at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 May 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
AUC of OPL-002 (time frame: 0 to 48 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 May 2021.