Healthy SubjectsPhase 1NCT04520360
Bioavailability and Food Effect Study of 3 Types of Carisbamate
A Phase 1 study testing Carisbamate in people with Healthy Subjects, run by SK Life Science, Inc. at 1 site in United States.
Trial summary
This study is designed to examine the relative bioavailability of three carisbamate formulations (Oral Suspension Type 1, Oral Suspension Type 2, and a 300 mg Oral Tablet) and to assess the effect of food on the oral bioavailability of the Oral Suspension Type 2 and the 300 mg Oral Tablet. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Subjects
- What is being tested?
- Carisbamate
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Aug 2020to 6 Oct 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 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Male or female subjects of 18 to 50 years of age (inclusive)
- Able to read, understand, sign, and date a written informed consent form (ICF) before study participation at screening
- Agree to use 2 highly effective methods of contraception, including at least one barrier method
- Body mass index (BMI) between 18.0 and 30.0 kg/m2 (inclusive) at screening
- Judged to be in good health based on medical history, physical examination, and routine laboratory measurements (i.e., without clinically relevant pathology)
- Normal electrocardiogram (ECG) (12-lead), arterial blood pressure, and heart rate within the normal standard range used by the study center or considered not clinically significant by the Investigator and in agreement with the Sponsor
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- Able to understand and comply with protocol requirements and instructions and likely to complete the study as planned
- A female study subject of childbearing potential must agree to use one of the accepted contraceptive method from Screening, during the study, and for at least 90 days after the last dose of the study medication. Hormonal contraceptives alone will not be considered an adequate method of contraception.
- A female study subject must agree not to donate eggs (oocytes) during the study and for at least 90 days after the last dose of the study medication
- Females of non-childbearing potential who have undergone a sterilization procedure at least 6 months prior to dosing with official documentation (e.g., hysteroscopic sterilization, bilateral tubal ligation or bilateral salpingectomy, hysterectomy, or bilateral oophorectomy) or become postmenopausal with amenorrhea for at least 1 year prior to dosing and have follicle-stimulating hormone (FSH) serum levels consistent with postmenopausal status as per Principal Investigator's judgment
- Subjects are able and willing to consume a high-fat meal within a 30 minute timeframe
Who cannot join
- 1. History of any illness or condition that, in the opinion of the Investigator, might confound the results of the study or pose additional risks in administering study drug to the subjects
- Smokers (subjects who have smoked within 6 months prior to screening or those subjects with a positive result from the smoking screening assay)
- Cholecystectomy and/or surgery of the gastrointestinal tract that could interfere with pharmacokinetics of the study drug (except appendectomy and simple hernia repair).
- Regular treatment with prescription medications. Subjects should have ended any prescription medications at least 14 days before the first dosing of the study drug. Potential subjects should only stop any prescribed medication at the direction of a physician or qualified medical professional.
- Regular treatment with nonprescription medications. Subjects should have ended any nonprescription medications at least 14 days before the first dosing of the study drug. Potential subjects should consult with a physician or qualified medical professional before stopping any regular treatment with nonprescription medication.
- Consumption of herbal medications, dietary supplements, and specific fruit products. Subjects should have stopped consumption of herbal medications or dietary supplements (e.g., St. John's Wort, ginkgo biloba, and garlic supplements), vitamins, and grapefruit or grapefruit juice, or Seville oranges at least 14 days before the first dosing of study drug.
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- History of drug or alcohol abuse or addiction within 2 years before the start of study drug dosing, or a positive test results for alcohol or drugs of abuse, such as amphetamine, barbiturate, benzodiazepine, cocaine, methadone, opiates, oxycodone, phencyclidine, propoxyphene, cannabinoid (THC), MDMA (Ecstasy), methaqualone, and tricyclic antidepressant (TCA).
- Regular consumption of more than 2 units of alcoholic beverages per day or more than 14 units per week (1 unit of alcohol equals 1 pint [473 mL] of beer or lager, 1 glass [125 mL] of wine, 25 mL shot of 40% spirit) before screening. Subjects may not consume any alcohol from 72 hours before the first dosing of study drug through the completion of the last PK sampling.
- Consumption of an average of more than 5 servings per day of coffee, tea, chocolate, cola, or other caffeinated or methyl xanthine beverages before screening. Subjects may not consume any tea, coffee, chocolate, and other foods and beverages containing caffeine and other methyl xanthine derivatives from 48 hours prior to dosing until the collection of the last PK sample.
- Participation in a clinical study involving administration of either an investigational or a marketed drug within 2 months or 7 half-lives (whichever is longer) before screening.
- Blood donation or a significant loss of blood within 60 days of the start of study drug dosing or donation of more than 1 unit of plasma within 7 days before screening.
- Positive result at screening for any of the following infectious disease tests: hepatitis B surface antigen (HBsAg), hepatitis C virus antibody (HCV Ab), human immunodeficiency virus antigen and antibody (HIV-1/2 Ag/Ab)
- Illness within 5 days before the start of study drug dosing ("illness" is defined as an acute [serious or non-serious] condition [e.g., the flu or the common cold])
- History of any known relevant allergy/hypersensitivity (including allergy to the trial medication or its excipients)
- Women who are pregnant or breastfeeding
- Subject who is judged not eligible for study participation by Investigator
- Subject is at imminent risk of suicide (positive response to question 4 or 5 on the C-SSRS) or had a suicide attempt within 6 months prior to the Screening visit
Trial locations and contacts
1 site in 1 country.
United States1 site
PRA Health Sciences- Salt Lake City
Salt Lake City, Utah, 84124
About this study
Official title: A Single-Center, Open-Label,Randomized, Crossover Study to Evaluate the Relative Bioavailability and Food Effect of a New Oral Suspension and Tablet Formulation of Carisbamate (YKP509) in Healthy Adult Subjects
This study is designed to examine the relative bioavailability of three carisbamate formulations (Oral Suspension Type 1, Oral Suspension Type 2, and a 300 mg Oral Tablet) and to assess the effect of food on the oral bioavailability of the Oral Suspension Type 2 and the 300 mg Oral Tablet.
Read the detailed description
This is a single center, open-label, randomized, 5-period, 10-sequence study designed to assess each treatment in 30 healthy subjects enrolled in the study. The five treatments tested using a single oral administration will be: (1) Oral Suspension Type 1, 300 mg Oral Tablet, Oral Suspension Type 2 all under fasted conditions and (2) Oral Suspension Type 2, 300 mg Oral Tablet under fed conditions. Each dose is followed by at least a seven-day washout period. The sequence and period arrangement will be constructed based on the Williams design to ensure the study is balanced with respect to first-order carry-over effects.
- Conditions
- Healthy Subjects
- Being tested
- Carisbamate
- Keywords
- Carisbmate, Lennox-Gastaut syndrome (LGS), Healthy Volunteers
- Medical subject headings
- Lennox Gastaut Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CarisbamateDrug
Also called YKP509
Carisbamate is currently under investigation as an adjuvant antiepileptic therapy in Lennox-Gastaut patients. Lennox-Gastaut syndrome (LGS) is a rare and highly debilitating form of childhood epilepsy that typically is diagnosed between 2 and 8 years of age, with peak onset at 3 to 5 years of age, and frequently persists into adulthood. Treatment options are limited and complicated by the multiple seizure types associated with LGS. Given the breadth of physical and cognitive disabilities associated with LGS, the development of antiseizure medications with appropriate oral dosing forms is needed to ensure administration feasibility and compliance in the target population.
| Study group | Role | What they receive |
|---|---|---|
| Types of Carisbamate | Experimental | 1. A single 300 mg oral dose of the Oral Suspension Type 1 under fasting conditions
2. A single 300 mg oral dose of Oral Suspension Type 2 under fasting conditions
3. A single 300 mg oral dose of Oral Suspension Type 2 under fed conditions
4. A single oral dose of the 300 mg Oral Tablet under fasting conditions
5. A single oral dose of the 300 mg Oral Tablet under fed conditions Receives: Drug: Carisbamate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Treatment-Emergent Adverse Events
To evaluate the safety and tolerability of each carisbamate formulation administered under either fed (Oral Suspension Type 2 and the 300 mg Oral Tablet) or fasted (all formulations) conditions. Evaluation of any abnormal laboratory safety results, ECGs or other incidence of treatment-emergent adverse events will be monitored. Subjects will also be assessed on the risk for suicidality via the C-SSRS (Columbia Suicide Severity Rating Scale)
Measured: 35 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2020
- Study start27 Aug 2020
- Primary completion6 Oct 2021
- Study completion6 Oct 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy SubjectsStudies 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- This is a single center, open-label, randomized, 5-period, 10-sequence study designed to assess each treatment in all subjects enrolled in the study. The five treatments tested using a single oral administration will be: (1) Oral Suspension Type 1, 300 mg Oral Tablet, Oral Suspension Type 2 all under fasted conditions and (2) Oral Suspension Type 2, 300 mg Oral Tablet under fed conditions. Each dose is followed by at least a seven-day washout period. The sequence and period arrangement will be constructed based on the Williams design to ensure the study is balanced with respect to first-order carry-over effects.
- Masking
- None (open label)
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- SK Life Science, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- PRA Health Sciences
- Responsible party
- Sponsor
- Investigators
- Ry R Forseth, Ph.D., Study chair, SK Life Science, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04520360
- Sponsor's protocol ID
- YKP509C005
- Status last verified
- Jul 2020
- First submitted
- 5 Aug 2020
- Last updated
- 7 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-Center, Open-Label,Randomized, Crossover Study to Evaluate the Relative Bioavailability and Food Effect of a New Oral Suspension and Tablet Formulation of Carisbamate (YKP509) in Healthy Adult Subjects
- ClinicalTrials.gov ID
- NCT04520360
- Acronym / sponsor ID
- YKP509C005
- Conditions
- Healthy Subjects
- Keywords
- Carisbmate, Lennox-Gastaut syndrome (LGS), Healthy Volunteers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- SK Life Science, Inc.Industry (pharma, biotech, devices)
- Collaborators
- PRA Health Sciences
- Study start
- 27 Aug 2020 (actual)
- Primary completion
- 6 Oct 2021 (actual)
- Study completion
- 6 Oct 2021 (actual)
- First posted
- 20 Aug 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 study is designed to examine the relative bioavailability of three carisbamate formulations (Oral Suspension Type 1, Oral Suspension Type 2, and a 300 mg Oral Tablet) and to assess the effect of food on the oral bioavailability of the Oral Suspension Type 2 and the 300 mg Oral Tablet.
Detailed description
This is a single center, open-label, randomized, 5-period, 10-sequence study designed to assess each treatment in 30 healthy subjects enrolled in the study. The five treatments tested using a single oral administration will be: (1) Oral Suspension Type 1, 300 mg Oral Tablet, Oral Suspension Type 2 all under fasted conditions and (2) Oral Suspension Type 2, 300 mg Oral Tablet under fed conditions. Each dose is followed by at least a seven-day washout period. The sequence and period arrangement will be constructed based on the Williams design to ensure the study is balanced with respect to first-order carry-over effects.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This is a single center, open-label, randomized, 5-period, 10-sequence study designed to assess each treatment in all subjects enrolled in the study. The five treatments tested using a single oral administration will be: (1) Oral Suspension Type 1, 300 mg Oral Tablet, Oral Suspension Type 2 all under fasted conditions and (2) Oral Suspension Type 2, 300 mg Oral Tablet under fed conditions. Each dose is followed by at least a seven-day washout period. The sequence and period arrangement will be constructed based on the Williams design to ensure the study is balanced with respect to first-order carry-over effects.
| Arm | Type | Receives |
|---|---|---|
| Types of Carisbamate | Experimental | Drug: Carisbamate1. A single 300 mg oral dose of the Oral Suspension Type 1 under fasting conditions 2. A single 300 mg oral dose of Oral Suspension Type 2 under fasting conditions 3. A single 300 mg oral dose of Oral Suspension Type 2 under fed conditions 4. A single oral dose of the 300 mg Oral Tablet under fasting conditions 5. A single oral dose of the 300 mg Oral Tablet under fed conditions |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (11 listed)
- Male or female subjects of 18 to 50 years of age (inclusive)
- Able to read, understand, sign, and date a written informed consent form (ICF) before study participation at screening
- Agree to use 2 highly effective methods of contraception, including at least one barrier method
- Body mass index (BMI) between 18.0 and 30.0 kg/m2 (inclusive) at screening
- Judged to be in good health based on medical history, physical examination, and routine laboratory measurements (i.e., without clinically relevant pathology)
Key exclusion criteria (17 listed)
- 1. History of any illness or condition that, in the opinion of the Investigator, might confound the results of the study or pose additional risks in administering study drug to the subjects
- Smokers (subjects who have smoked within 6 months prior to screening or those subjects with a positive result from the smoking screening assay)
- Cholecystectomy and/or surgery of the gastrointestinal tract that could interfere with pharmacokinetics of the study drug (except appendectomy and simple hernia repair).
- Regular treatment with prescription medications. Subjects should have ended any prescription medications at least 14 days before the first dosing of the study drug. Potential subjects should only stop any prescribed medication at the direction of a physician or qualified medical professional.
- Regular treatment with nonprescription medications. Subjects should have ended any nonprescription medications at least 14 days before the first dosing of the study drug. Potential subjects should consult with a physician or qualified medical professional before stopping any regular treatment with nonprescription medication.
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 |
|---|---|---|
| CarisbamateAlso: YKP509Carisbamate is currently under investigation as an adjuvant antiepileptic therapy in Lennox-Gastaut patients. Lennox-Gastaut syndrome (LGS) is a rare and highly debilitating form of childhood epilepsy that typically is diagnosed between 2 and 8 years of age, with peak onset at 3 to 5 years of age, and frequently persists into adulthood. Treatment options are limited and complicated by the multiple seizure types associated with LGS. Given the breadth of physical and cognitive disabilities associated with LGS, the development of antiseizure medications with appropriate oral dosing forms is needed to ensure administration feasibility and compliance in the target population. | Drug | Types of Carisbamate |
Primary outcome
Incidence of Treatment-Emergent Adverse Events
Time frame: 35 days
To evaluate the safety and tolerability of each carisbamate formulation administered under either fed (Oral Suspension Type 2 and the 300 mg Oral Tablet) or fasted (all formulations) conditions. Evaluation of any abnormal laboratory safety results, ECGs or other incidence of treatment-emergent adverse events will be monitored. Subjects will also be assessed on the risk for suicidality via the C-SSRS (Columbia Suicide Severity Rating Scale)
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 7 Oct 2021.
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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.
Ry R Forseth, Ph.D. study chair
SK Life Science, Inc.
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 Carisbamate in people with Healthy Subjects, run by SK Life Science, Inc. at 1 site in United States.
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 11 inclusion and 17 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 7 Oct 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 States. 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?
Incidence of Treatment-Emergent Adverse Events (time frame: 35 days). 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 7 Oct 2021.