Healthy VolunteersPhase 1NCT03633591
A Study Assessing the Safety and Pharmacokinetic Profile of Modified Release Formulations of Tolcapone
A Phase 1 study testing Tolcapone, Tolcapone Modified Release Prototype and Tolcapone Divided Dose in people with Healthy Volunteers, run by Corino Therapeutics, Inc. at 1 site in United Kingdom.
Trial summary
The purpose of this study is to assess the pharmacokinetic profiles of tolcapone in healthy subjects after administration of one or two oral doses of multiple modified release prototype formulations. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- Tolcapone, Tolcapone Modified Release Prototype and Tolcapone Divided Dose
- 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
- 25 Jun 2018to 22 Oct 2018
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy males or non-pregnant, non-lactating healthy females
- Age 18 to 65 years of age at the time of signing informed consent
- Body mass index (BMI) of 18.0 to 32.0 kg/m2 or, if outside the range, considered not clinically significant by the investigator
- Must be willing and able to communicate and participate in the whole study
- Must provide written informed consent
- Must agree to use an adequate method of contraception
Who cannot join
- Subjects who have received any IMP in a clinical research study within the previous 3 months prior to first dose.
- Subjects who are study site employees, or immediate family members of a study site or sponsor employee.
- Subjects who have previously been enrolled in this study.
- History of any drug or alcohol abuse in the past 2 years.
- Current smokers and those who have smoked within the last 12 months. A breath carbon monoxide reading of greater than 10 ppm at screening
- Current users of e-cigarettes and nicotine replacement products and those who have used these products within the last 12 months
Show all 22Show fewer
- Females of childbearing potential who are pregnant or lactating
- Subjects who do not have suitable veins for multiple venepunctures / cannulation as assessed by the investigator at screening
- Clinically significant abnormal biochemistry, hematology or urinalysis as judged by the investigator
- Hemoglobin below the lower limit of normal
- ALT or AST outside the normal reference range at screening or admission.
- Confirmed positive drugs of abuse test result
- Positive hepatitis B surface antigen (HBsAg), hepatitis C virus antibody (HCV Ab) or human immunodeficiency virus (HIV) results
- History of clinically significant cardiovascular, neurological, renal, hepatic, chronic respiratory or gastrointestinal disease, or psychiatric disorder, as judged by the investigator
- Subjects with a history of cholecystectomy or gall stones
- Serious adverse reaction or serious hypersensitivity to any drug, the formulation excipients, or lactose intolerance
- Presence or history of clinically significant allergy requiring treatment, as judged by the investigator.
- Donation or loss of greater than 400 mL of blood within the previous 3 months
- Subjects who are taking, or have taken, any prescribed or over-the-counter drug or herbal remedies in the 14 days before IMP administration.
- Contraindication for Tasmar®
- Failure to satisfy the investigator of fitness to participate for any other reason
- NOTE: Other inclusion/exclusion criteria may apply, per protocol
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Quotient Sciences
Ruddington, Nottingham, NG11 6JS
About this study
Official title: A Phase 1, Single-Part, 6-Period, Sequential, Non-Randomized, Open-Label Study Designed to Evaluate the Pharmacokinetic Profile of Tolcapone Following Administration of Modified Release Prototype Formulations and an Experimental Divided Dose Regimen in Healthy Subjects
The purpose of this study is to assess the pharmacokinetic profiles of tolcapone in healthy subjects after administration of one or two oral doses of multiple modified release prototype formulations.
- Conditions
- Healthy Volunteers
- Being tested
- Tolcapone, Tolcapone Modified Release Prototype, Tolcapone Divided Dose
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TolcaponeDrug
Also called Tasmar
Multiple doses of tolcapone tablets in the fasted state
Tolcapone Modified Release PrototypeDrug
A single dose of tolcapone modified release prototype in the fasted state
Tolcapone Divided DoseDrug
Tolcapone (suspension) in equal divided doses in the fasted state
Tolcapone Modified Release PrototypeDrug
A single dose of tolcapone modified release prototype (optionally two doses or fed state of prior MR prototype)
| Study group | Role | What they receive |
|---|---|---|
| Modified Release Prototypes of Tolcapone | Experimental | Not described Receives: Drug: Tolcapone; Drug: Tolcapone Modified Release Prototype; Drug: Tolcapone Divided Dose |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacokinetic Assessment: Time to maximum concentration (Tmax)
Time to maximum concentration (Tmax)
Measured: Pre-dose to 24 hours post-dose
Pharmacokinetic Assessment: Maximum observed concentration (Cmax)
Maximum observed concentration (Cmax)
Measured: Pre-dose to 24 hours post-dose
Pharmacokinetic Assessment: Area under the curve (AUC)
Area under the curve (AUC)
Measured: Pre-dose to 24 hours post-dose
Pharmacokinetic Assessment: Plasma half-life (t1/2)
Plasma half-life (t1/2)
Measured: Pre-dose to 24 hours post-dose
Pharmacokinetic Assessment: Relative bioavailability (Frel)
Relative bioavailability (Frel)
Measured: Pre-dose to 24 hours post-dose
Secondary outcomes (6)
Pharmacokinetic Assessment of 3-O-Methyltolcapone: Time to maximum concentration (Tmax)
Time to maximum concentration (Tmax)
Measured: Pre-dose to 24 hours post-dose
Pharmacokinetic Assessment of 3-O-Methyltolcapone: Maximum observed concentration (Cmax)
Maximum observed concentration (Cmax)
Measured: Pre-dose to 24 hours post-dose
Pharmacokinetic Assessment of 3-O-Methyltolcapone: Area under the curve (AUC)
Area under the curve (AUC)
Measured: Pre-dose to 24 hours post-dose
Pharmacokinetic Assessment of 3-O-Methyltolcapone: Plasma half-life (t1/2)
Plasma half-life (t1/2)
Measured: Pre-dose to 24 hours post-dose
Pharmacokinetic Assessment of 3-O-Methyltolcapone: Relative Bioavailability (Frel)
Relative Bioavailability (Frel)
Measured: Pre-dose to 24 hours post-dose
Number of subjects reporting treatment-related Adverse Events (AEs)
Abnormalities in safety laboratory tests, vital signs, electrocardiogram, physical examination that meet the protocol definition will be captured as AEs
Measured: Screening to 10 days following last dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2018
- Study start25 Jun 2018
- Primary completion22 Oct 2018
- Study completion22 Oct 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Corino Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Quotient Sciences
- Responsible party
- Sponsor
- Investigators
- Litza McKenzie, Principal investigator, Quotient Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03633591
- Sponsor's protocol ID
- TOLC101MR
- Other IDs
- 2017-003070-13, 2017
- Status last verified
- Jan 2019
- First submitted
- 10 Aug 2018
- Last updated
- 31 Jan 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Single-Part, 6-Period, Sequential, Non-Randomized, Open-Label Study Designed to Evaluate the Pharmacokinetic Profile of Tolcapone Following Administration of Modified Release Prototype Formulations and an Experimental Divided Dose Regimen in Healthy Subjects
- ClinicalTrials.gov ID
- NCT03633591
- Acronym / sponsor ID
- TOLC101MR
- Conditions
- Healthy Volunteers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Corino Therapeutics, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Quotient Sciences
- Study start
- 25 Jun 2018 (actual)
- Primary completion
- 22 Oct 2018 (actual)
- Study completion
- 22 Oct 2018 (actual)
- First posted
- 16 Aug 2018 (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.
The purpose of this study is to assess the pharmacokinetic profiles of tolcapone in healthy subjects after administration of one or two oral doses of multiple modified release prototype formulations.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Modified Release Prototypes of Tolcapone | Experimental | Drug: Tolcapone, Drug: Tolcapone Modified Release Prototype, Drug: Tolcapone Divided Dose |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Healthy males or non-pregnant, non-lactating healthy females
- Age 18 to 65 years of age at the time of signing informed consent
- Body mass index (BMI) of 18.0 to 32.0 kg/m2 or, if outside the range, considered not clinically significant by the investigator
- Must be willing and able to communicate and participate in the whole study
- Must provide written informed consent
Key exclusion criteria (22 listed)
- Subjects who have received any IMP in a clinical research study within the previous 3 months prior to first dose.
- Subjects who are study site employees, or immediate family members of a study site or sponsor employee.
- Subjects who have previously been enrolled in this study.
- History of any drug or alcohol abuse in the past 2 years.
- Current smokers and those who have smoked within the last 12 months. A breath carbon monoxide reading of greater than 10 ppm at screening
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 |
|---|---|---|
| TolcaponeAlso: TasmarMultiple doses of tolcapone tablets in the fasted state | Drug | Modified Release Prototypes of Tolcapone |
| Tolcapone Modified Release PrototypeA single dose of tolcapone modified release prototype in the fasted state | Drug | Modified Release Prototypes of Tolcapone |
| Tolcapone Divided DoseTolcapone (suspension) in equal divided doses in the fasted state | Drug | Modified Release Prototypes of Tolcapone |
| Tolcapone Modified Release PrototypeA single dose of tolcapone modified release prototype (optionally two doses or fed state of prior MR prototype) | Drug | Modified Release Prototypes of Tolcapone |
Primary outcome
Pharmacokinetic Assessment: Time to maximum concentration (Tmax)
Time frame: Pre-dose to 24 hours post-dose
Time to maximum concentration (Tmax)
Pharmacokinetic Assessment: Maximum observed concentration (Cmax)
Time frame: Pre-dose to 24 hours post-dose
Maximum observed concentration (Cmax)
Pharmacokinetic Assessment: Area under the curve (AUC)
Time frame: Pre-dose to 24 hours post-dose
Area under the curve (AUC)
Pharmacokinetic Assessment: Plasma half-life (t1/2)
Time frame: Pre-dose to 24 hours post-dose
Plasma half-life (t1/2)
Pharmacokinetic Assessment: Relative bioavailability (Frel)
Time frame: Pre-dose to 24 hours post-dose
Relative bioavailability (Frel)
6 secondary outcomes
Pharmacokinetic Assessment of 3-O-Methyltolcapone: Time to maximum concentration (Tmax)
Time frame: Pre-dose to 24 hours post-dose
Pharmacokinetic Assessment of 3-O-Methyltolcapone: Maximum observed concentration (Cmax)
Time frame: Pre-dose to 24 hours post-dose
Pharmacokinetic Assessment of 3-O-Methyltolcapone: Area under the curve (AUC)
Time frame: Pre-dose to 24 hours post-dose
Pharmacokinetic Assessment of 3-O-Methyltolcapone: Plasma half-life (t1/2)
Time frame: Pre-dose to 24 hours post-dose
Pharmacokinetic Assessment of 3-O-Methyltolcapone: Relative Bioavailability (Frel)
Time frame: Pre-dose to 24 hours post-dose
Number of subjects reporting treatment-related Adverse Events (AEs)
Time frame: Screening to 10 days following last dose
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 31 Jan 2019.
- Individual participant dataSharing planned: No
Related trials for Healthy Volunteers
Not yet recruiting
Neuroergonomic Analysis of a Brain-Computer Interface Device (BCI)
Healthy Volunteers - Male and Female
RecruitingPhase 1
First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
Healthy Volunteer, Atopic Dermatitis
Not yet recruitingObservational study
Establishment of Biobank of Nasal Epithelium Samples From Healthy Volunteers
Healthy
RecruitingObservational study
Improved Methods of Cell Selection for Bone Marrow Transplant Alternatives
Graft-Versus-Host Disease, Graft-versus-leukemia
Not yet recruitingObservational study
Screening Protocol
Pain
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.
Litza McKenzie principal investigator
Quotient Sciences
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 Tolcapone, Tolcapone Modified Release Prototype and Tolcapone Divided Dose in people with Healthy Volunteers, run by Corino Therapeutics, Inc. 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 6 inclusion and 22 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 31 Jan 2019. 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?
Pharmacokinetic Assessment: Time to maximum concentration (Tmax) (time frame: Pre-dose to 24 hours post-dose). The study lists 5 primary outcomes in all. 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 31 Jan 2019.