Healthy Volunteers in Fed and Fasted StatePhase 1Fed-FastNCT04449250
Fed-Fast Crossover Study to Assess the Effect of Food With CTx-1301 in Healthy Subjects
A Phase 1 study testing Dexmethylphenidate in people with Healthy Volunteers in Fed and Fasted State, run by Cingulate Therapeutics at 1 site in United States.
Trial summary
The primary purpose of this study is to assess the effect of food on the rate and extent of absorption and the overall bioavailability of a single dose of CTx-1301 25 mg trimodal tablets in healthy adult volunteers. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers in Fed and Fasted State
- What is being tested?
- Dexmethylphenidate
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Sep 2022to 14 Oct 2022
- 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
- Gender a. Male or Female
- Age
- Aged between 18 and 50 years inclusive.
- Weight and BMI
- Body weight ≥ 50 kg
- BMI ≥ 18 and ≤ 35
Show all 23Show fewer
- Compliance
- Understands and is willing, able, and likely to comply with all study procedures and restrictions.
- Able to fully consume the required fed meal within 30 minutes without substitutions.
- If sexually active, male subjects must use an acceptable method of contraception, which includes the double-barrier method (condom and spermicide) or agree to remain abstinent from heterosexual intercourse from Day -1 (check-in), during the study, and for 90 days following the last administration of study drug.
- If sexually active, female subjects of child-bearing potential must use an acceptable method of contraception, which includes, hormonal contraceptives, intrauterine device (IUD) with or without hormones, or double-barrier method (e.g. condom and spermicide), or remain abstinent from heterosexual intercourse for 30 days prior to screening during the study and for 30 days following the last administration of study drug.
- Male subjects must agree not to donate sperm during the study and for 90 days following the last administration of study drug.
- Female subjects must agree not to donate eggs during the study and for 30 days following the last administration of study drug.
- Consent
- Demonstrates understanding of the study and willingness to participate as evidenced by voluntary written informed consent (signed and dated) obtained before any study-related activities are performed.
- General Health
- Good general health (in the opinion of an investigator) with no clinically significant or relevant abnormalities on medical history or physical examination which could affect the safety of the subject or integrity of study data.
- No signs of illness (fever or vomiting) within 24-hours of check-in at Day -1
- Subject has sufficient venous access at the time of screening to allow cannulation and/or venipuncture to obtain the required volume of blood for this study.
- Smoking/Caffeine/Alcohol
- Subject must be a non-smoker (i.e., does not use any form of nicotine products) as defined by exclusion #4 in this protocol.
- Subject must be able to refrain from caffeine or xanthine-containing beverages or foods (e.g., tea, coffee, chocolate, cola) for 10 hours prior to check-in at Day -1 and for the duration of the study.
- Subject must be able to refrain from using alcohol 48 hrs. prior to Day -1 and for the duration of the study.
Who cannot join
- Medical History
- Current and/or recurrent disease or illness that, in the opinion of an investigator, could affect the study conduct, study outcome, subject safety, or pharmacokinetic (PK) assessments (e.g., hepatic disorders, renal insufficiency, non-self-limiting gastrointestinal disorders, congestive heart failure).
- Current and/or previous history of any other serious, severe or unstable psychiatric illness which in the opinion of the investigator, may require treatment (e.g. ADD/ADHD, anxiety, psychosis, mood disorder, motor tics or suicidality) or make the subject unlikely to fully complete the study, and/or any condition that presents undue risk from the study medication or procedures.
- Subject cannot have suicidal thoughts within the last 6 months as supported by the Columbia Suicide Severity Rating Scale (C-SSRS).
- Positive test results for Human Immunodeficiency Virus (HIV)-1/HIV-2 antibodies, Hepatitis B surface antigen (HBsAg) or Hepatitis C virus antibody (HCVAb).
- A family history of sudden cardiac or unexplained death.
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- Any condition or abnormal laboratory finding that could result in harm to the subject, affect the outcome of the study, or suggest unstable medical illness.
- Any clinically significant psychiatric disorder or finding which the Investigator considers the subject disqualified from the study.
- Subject plans to undergo elective procedures/surgery at any time during the study.
- Subject has had surgery within the past 90 days.
- Subject of child-bearing potential is pregnant or planning to become pregnant during the duration of the study or within 30 days of the end of the study.
- Subject is breast-feeding during the study or within 30 days following the study.
- Positive result of COVID-19 testing at Day -1.
- Medications
- Subject has taken any medication that, in the opinion of an Investigator, has been shown to alter the PK of d-MPH.
- Use of any prescription medication within 14 days prior to Day -1 and/or use of any OTC medications (such as antacids, vitamins, minerals, dietary/herbal preparations, and nutritional supplements) within 7 days prior to Day -1, unless jointly approved by an Investigator and Sponsor. Subjects may not use these medications through the full duration of the study.
- Subjects are permitted to take hormonal contraceptives and hormone replacement therapy at acceptable levels if stable at least 30 days prior to Day -1, through the duration of the study, and for 30 days after the study ends.
- Acetaminophen (up to 2 grams per day) may be used during the study under the direction of the Investigator.
- COVID vaccine is allowed if taken at least 45 days prior to Day -1 iv. On a case-by-case basis, an Investigator is permitted to allow the use of certain concomitant medications, for example, to treat an AE, as long as an Investigator determines that the medication will not affect the subject's safety or study integrity (e.g., topical medications).
- Alcohol/Substance Abuse
- Recent history (within the last year) of alcohol or other substance abuse.
- Subject has positive urine alcohol test or urine screen for drugs of abuse at screening or check-in.
- Smoking a. Subject is a current smoker or has recently discontinued smoking (i.e., regular use of any nicotine-containing products within 3 months of screening). Occasional or social use of nicotine is acceptable.
- Allergy/Intolerance
- Subject has a history of allergy to d-MPH, to any component of the dosage form, or any other allergy, which, in the opinion of an Investigator, contraindicates their participation.
- Clinical Studies
- Receipt of an investigational drug within the 30 days before screening day. b. Previous participation in a CTx-1301 study.
- Personnel
- An employee of the sponsor, study site, or members of their immediate family.
- Blood a. Subject has donated blood within 56 days prior to screening, plasma within 7 days prior to screening, or experienced significant blood loss (excess of 500 mL) within 3 months prior to screening and for the duration of the study.
Trial locations and contacts
1 site in 1 country.
United States1 site
Dr. Vince Clinical Research
Overland Park, Kansas, 66212
About this study
Official title: An Open-label, Randomized, Single-dose, Two-period, Two-treatment (Fed vs Fasted), Two-sequence, Crossover Study in Healthy Adult Subjects to Assess the Effect of Food on the Absorption and Bioavailability of CTx-1301 (Dexmethylphenidate)
The primary purpose of this study is to assess the effect of food on the rate and extent of absorption and the overall bioavailability of a single dose of CTx-1301 25 mg trimodal tablets in healthy adult volunteers.
Read the detailed description
An open-label, randomized, single-dose, two-sequence, two-period, in-clinic crossover study with two treatments (fed vs fasted) in approximately 26 healthy adult subjects aged 18 to 50 years.
Fed arm: Following an overnight fast of 10.5 hours, subjects should begin and finish consuming the test meal within 30 minutes, prior to administration of CTx-1301 (25 mg). CTx-1301 (25 mg) should be administered with approximately 240 mL (8 fluid ounces) of water. No food should be allowed for at least 4 hours post-dose. Water can be allowed as desired except for at least one hour before and at least one hour after drug administration. Subjects should receive standardized meals as defined in the study schedule for the fed treatment arm.
Fasted arm: Following an overnight fast of 10.5 hours, subjects should be administered CTx-1301 (25 mg) with approximately 240 mL (8 fluid ounces) of water. No food should be allowed for at least 4 hours post-dose. Water can be allowed as desired except for at least one hour before and at least one hour after drug administration. Subjects should receive standardized meals as defined in the study schedule for the fasted treatment arm.
A high-fat (approximately 50 percent of total caloric content of the meal) and high-calorie (approximately 800 to 1000 calories) meal is used as the test meal for food-effect bioanalytical (BA) and fed bioequivalency (BE) studies. This test meal allows approximately 150, 250, and 500-600 calories from protein, carbohydrate, and fat, respectively. The test meal, eaten within 30 minutes prior to administration of CTx-1301, is two eggs fried in butter, two strips of bacon, two slices of toast with butter, four ounces of hash brown potatoes and eight ounces of whole milk.
- Being tested
- Dexmethylphenidate
- Keywords
- Healthy Normal Volunteers, Fed Study, Pharmacokinetics, Dexmethylphenidate, Bioavailability, d-MPH, dMPH
- Medical subject headings
- Fasting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DexmethylphenidateDrug
Subjects will be randomized to one of two sequences. Subjects will be dosed with 25 mg dose of CTx-1301 during each sequence. Subjects will serve as their own control.
| Study group | Role | What they receive |
|---|---|---|
| CTx-1301 Fasted | Active comparator | Subjects will receive CTx-1301 in a fasted state. Receives: Drug: Dexmethylphenidate |
| CTx-1301 Fed | Active comparator | Subjects will receive CTx-1301 in a fed state (high fat test meal). Receives: Drug: Dexmethylphenidate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacokinetic parameter (Cmax)
Maximum Concentration
Measured: Hour 0 to hour 28
Pharmacokinetic parameter (AUC0-inf)
Area Under the Curve from time 0 to infinity
Measured: Hour 0 to hour 28
Pharmacokinetic parameter (AUC0-last)
Area Under the Curve from time 0 to 28 hrs
Measured: Hour 0 to hour 28
Secondary outcomes (19)
Pharmacokinetic parameter K
Terminal Elimination Constant
Measured: Hour 0 to hour 28
Pharmacokinetic parameter T 1/2
Half Life
Measured: Hour 0 to hour 28
Pharmacokinetic parameter T max
Time of Maximum Concentration
Measured: Hour 0 to hour 28
Pharmacokinetic parameter T lag
Lag time
Measured: Hour 0 to hour 28
Pharmacokinetic parameter Cl/F
Apparent Clearance
Measured: Hour 0 to hour 28
Pharmacokinetic parameter Vd/F
Apparent Volume of Distribution
Measured: Hour 0 to hour 28
Partial AUC
Area Under the Curve
Measured: 0-3 hrs
Partial AUC
Area Under the Curve
Measured: 3-6 hrs
Partial AUC
Area Under the Curve
Measured: 3-7 hrs
Partial AUC
Area Under the Curve
Measured: 6-9 hrs
Partial AUC
Area Under the Curve
Measured: 7-12 hrs
Partial AUC
Area Under the Curve
Measured: 9-12 hrs
Partial AUC
Area Under the Curve
Measured: 12-16 hrs
Safety - ECG
Evaluation of changes in ECG measurements
Measured: Day -1 to Day 4
Safety - Vital Signs
Evaluation of changes in Vital Sign measurements
Measured: Day -1 to Day 4
Safety - Safety Labs
Evaluation of changes in Safety Lab measurements
Measured: Day -1 to Day 4
Safety - Physical Exam
Evaluation of changes in the Physical Exam
Measured: Day -1 to Day 4
Safety - C-SSRS
Evaluation of changes in the Suicidal Ideation
Measured: Day -1 to Day 4
Safety - Treatment Emergent Adverse Events (TEAEs)
Evaluation of Treatment Emergent Adverse Events (TEAEs)
Measured: Day -1 to Day 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2020
- Study start14 Sep 2022
- Primary completion14 Oct 2022
- Study completion14 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy Volunteers in Fed and Fasted StateStudies 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
- Model description
- Subjects will be randomized to one of two sequences: Sequence 1) Fasted: Fed or Sequence 2) Fed: Fasted
- Masking
- None (open label)
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cingulate Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Matt Brams, MD, Study director, Cingulate Therapeutics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04449250
- Sponsor's protocol ID
- CTx-1301-003
- Acronym
- Fed-Fast
- Status last verified
- Oct 2022
- First submitted
- 24 Jun 2020
- Last updated
- 20 Oct 2022
- 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 20 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Randomized, Single-dose, Two-period, Two-treatment (Fed vs Fasted), Two-sequence, Crossover Study in Healthy Adult Subjects to Assess the Effect of Food on the Absorption and Bioavailability of CTx-1301 (Dexmethylphenidate)
- ClinicalTrials.gov ID
- NCT04449250
- Acronym / sponsor ID
- Fed-Fast / CTx-1301-003
- Keywords
- Healthy Normal Volunteers, Fed Study, Pharmacokinetics, Dexmethylphenidate, Bioavailability, d-MPH, dMPH
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- Cingulate TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- 14 Sep 2022 (actual)
- Primary completion
- 14 Oct 2022 (actual)
- Study completion
- 14 Oct 2022 (actual)
- First posted
- 26 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.
The primary purpose of this study is to assess the effect of food on the rate and extent of absorption and the overall bioavailability of a single dose of CTx-1301 25 mg trimodal tablets in healthy adult volunteers.
Detailed description
An open-label, randomized, single-dose, two-sequence, two-period, in-clinic crossover study with two treatments (fed vs fasted) in approximately 26 healthy adult subjects aged 18 to 50 years.
Fed arm: Following an overnight fast of 10.5 hours, subjects should begin and finish consuming the test meal within 30 minutes, prior to administration of CTx-1301 (25 mg). CTx-1301 (25 mg) should be administered with approximately 240 mL (8 fluid ounces) of water. No food should be allowed for at least 4 hours post-dose. Water can be allowed as desired except for at least one hour before and at least one hour after drug administration. Subjects should receive standardized meals as defined in the study schedule for the fed treatment arm.
Fasted arm: Following an overnight fast of 10.5 hours, subjects should be administered CTx-1301 (25 mg) with approximately 240 mL (8 fluid ounces) of water. No food should be allowed for at least 4 hours post-dose. Water can be allowed as desired except for at least one hour before and at least one hour after drug administration. Subjects should receive standardized meals as defined in the study schedule for the fasted treatment arm.
A high-fat (approximately 50 percent of total caloric content of the meal) and high-calorie (approximately 800 to 1000 calories) meal is used as the test meal for food-effect bioanalytical (BA) and fed bioequivalency (BE) studies. This test meal allows approximately 150, 250, and 500-600 calories from protein, carbohydrate, and fat, respectively. The test meal, eaten within 30 minutes prior to administration of CTx-1301, is two eggs fried in butter, two strips of bacon, two slices of toast with butter, four ounces of hash brown potatoes and eight ounces of whole milk.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Subjects will be randomized to one of two sequences: Sequence 1) Fasted: Fed or Sequence 2) Fed: Fasted
| Arm | Type | Receives |
|---|---|---|
| CTx-1301 Fasted | Active comparator | Drug: DexmethylphenidateSubjects will receive CTx-1301 in a fasted state. |
| CTx-1301 Fed | Active comparator | Drug: DexmethylphenidateSubjects will receive CTx-1301 in a fed state (high fat test meal). |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (23 listed)
- Gender a. Male or Female
- Age
- Weight and BMI
- Compliance
- Consent
Key exclusion criteria (30 listed)
- Medical History
- Medications
- Alcohol/Substance Abuse
- Smoking a. Subject is a current smoker or has recently discontinued smoking (i.e., regular use of any nicotine-containing products within 3 months of screening). Occasional or social use of nicotine is acceptable.
- Allergy/Intolerance
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 |
|---|---|---|
| DexmethylphenidateSubjects will be randomized to one of two sequences. Subjects will be dosed with 25 mg dose of CTx-1301 during each sequence. Subjects will serve as their own control. | Drug | CTx-1301 Fasted, CTx-1301 Fed |
Primary outcome
Pharmacokinetic parameter (Cmax)
Time frame: Hour 0 to hour 28
Maximum Concentration
Pharmacokinetic parameter (AUC0-inf)
Time frame: Hour 0 to hour 28
Area Under the Curve from time 0 to infinity
Pharmacokinetic parameter (AUC0-last)
Time frame: Hour 0 to hour 28
Area Under the Curve from time 0 to 28 hrs
19 secondary outcomes
Pharmacokinetic parameter K
Time frame: Hour 0 to hour 28
Pharmacokinetic parameter T 1/2
Time frame: Hour 0 to hour 28
Pharmacokinetic parameter T max
Time frame: Hour 0 to hour 28
Pharmacokinetic parameter T lag
Time frame: Hour 0 to hour 28
Pharmacokinetic parameter Cl/F
Time frame: Hour 0 to hour 28
Pharmacokinetic parameter Vd/F
Time frame: Hour 0 to hour 28
Partial AUC
Time frame: 0-3 hrs
Partial AUC
Time frame: 3-6 hrs
Partial AUC
Time frame: 3-7 hrs
Partial AUC
Time frame: 6-9 hrs
Partial AUC
Time frame: 7-12 hrs
Partial AUC
Time frame: 9-12 hrs
Partial AUC
Time frame: 12-16 hrs
Safety - ECG
Time frame: Day -1 to Day 4
Safety - Vital Signs
Time frame: Day -1 to Day 4
Safety - Safety Labs
Time frame: Day -1 to Day 4
Safety - Physical Exam
Time frame: Day -1 to Day 4
Safety - C-SSRS
Time frame: Day -1 to Day 4
Safety - Treatment Emergent Adverse Events (TEAEs)
Time frame: Day -1 to Day 4
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 20 Oct 2022.
- 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.
Matt Brams, MD study director
Cingulate Therapeutics
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 Dexmethylphenidate in people with Healthy Volunteers in Fed and Fasted State, run by Cingulate Therapeutics 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 23 inclusion and 30 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 20 Oct 2022. 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?
Pharmacokinetic parameter (Cmax) (time frame: Hour 0 to hour 28). The study lists 3 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 20 Oct 2022.