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Healthy Volunteers in Fed and Fasted StatePhase 1Fed-FastNCT07119073

In-clinic Crossover Study in Subjects With Two Treatments (Fed vs Fasted)

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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

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 50 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
What is being tested?
Dexmethylphenidate
Could I receive a placebo?
No, everyone receives an active treatment
How many people
25 participants
Where
1 siteUnited States
Study dates
31 Oct 2024to 27 Dec 2024
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
  • Male or Female
  • Age
  • Aged between 18 and 50 years inclusive. Weight and BMI
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  • Body weight ≥ 50 kg
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  • BMI ≥ 18 and ≤ 30
  • 4. 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 Qualification day, 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.
  • 5. 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.
  • 6. General Health
  • Good general health (in the opinion of an investigator) with no clinically significant or relevant abnormalities on medical history, laboratory results, 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 admission on Qualification day and 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.
  • 7. Smoking/Caffeine/Alcohol
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  • 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 24 hours prior to admission on Qualification day, check-in at Day -1 and for the duration of the stay at the study center until EOS.
  • Subject must be able to refrain from using alcohol 48 hrs. prior to admission on Qualification day, check-in at Day -1 and for the duration of the stay at the study center until EOS.
  • 8. Medications
  • Subject must be willing and able to take stimulant medications during participation in this trial.
  • 9. Qualification
  • Subject satisfactorily completes the Qualification day, is able to safely tolerate 30 mg Focalin™ XR, and general behavior suggests that the subject could successfully complete the study in the opinion of an investigator.

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, weight loss surgeries).
  • Any clinically significant history including but not limited to arterial hypertension, pulmonary arterial hypertension, myocardial infarction, peripheral vascular disease, stroke, or evidence of other cardiovascular disease or disorder, including but not limited to ECG abnormalities such as:
  • QT interval measurement corrected for heart rate according to the Fridericia rule (QTcF) >450 msec for males or >470 msec for female subjects during controlled rest at screening, qualification, and Day -1,
  • Family history of long QT syndrome,
  • Family history of congenital QT prolongation,
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  • PR (PQ) interval shortening <120 msec (PR <120 msec but >110 msec is acceptable if there is no evidence of ventricular pre-excitation),
  • PR (PQ) interval prolongation (>220 msec), intermittent second-degree (Wenckebach block while asleep or in deep rest is not exclusionary), or third-degree atrioventricular block,
  • Persistent or intermittent complete bundle branch block (BBB) or intraventricular conduction delay (IVCD) with QRS >110 msec.
  • 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. 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 has had 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.
  • 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.
  • Medications a. 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 Qualification and 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 Qualification and Day -1, unless jointly approved by an Investigator and Sponsor. Subjects may not use these medications for the full duration of the stay at the study center until EOS.
  • Subjects are permitted to take hormonal contraceptives and hormone replacement therapy at acceptable levels if stable at least 30 days prior to Qualification, 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 Qualification Protocol CTx-1301-013 Version 1.0 Page 25 of 49 CONFIDENTIAL 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
  • Lifetime history of alcohol or other substance abuse. b. Subject has positive urine alcohol test or urine screen for drugs of abuse at screening, qualification or check-in. (Screening visit urine MPH screen results are not required prior to Qualification day but are necessary prior to randomization on Day -1. Day-1 urine MPH screen results are not required prior to dosing in each Period).
  • Smoking
  • Subject is a current smoker or has recently discontinued smoking (i.e., regular use of any nicotinecontaining products within 3 months of screening). Occasional, social use, or routine environmental exposure to 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
  • 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

Other trials in United States

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 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 50 mg trimodal tablets in healthy adult volunteers.

Read the detailed description

Fasted Arm: Following an overnight fast of at least 10.5 hours prior to dosing, subjectsshould be administered CTx-1301 (50 mg) with approximately240 mL (8 fluidounces) 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.

Fed Arm: Following an overnight fast of at least 10.5 hours prior to dosing, subjects should begin consuming the test meal 30 minutes prior to administration ofCTx-1301. CTx-1301 (50 mg) should be administered 30 minutes after thestart of the meal. CTx-1301 (50 mg) should be administered with approximately240 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 leastone hour before and at least one hour after drug administration. Subjects will receive the high-fat meal as described below for the fed treatment arm and standardized meals for all other meals.

A high-fat (approximately 50 percent of total caloric content of the meal) and high-calorie (800 to 1000 calories) meal is used as the test meal for food-effect bioavailability (BA) and fed bioequivalence (BE) studies. This test meal allows 150, 250, and 500-600 calories from protein, carbohydrate, and fat, respectively. The test meal must be entirely consumed within 30 minutes prior to administration of CTx-1301; the test meal consists of 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 50 mg dose of Cox-1301 during each sequence. Subjects will serve as their own control.

Study groups in NCT07119073
Study groupRoleWhat they receive
CTx-1301 FastedActive comparatorSubjects will receive CTx-1301 in a fasted state
Receives: Drug: Dexmethylphenidate
CTx-1301 FedActive comparatorSubjects 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.

  1. Pharmacokinetic parameter (Cmax)

    Maximum Concentration

    Measured: Hour 0 to hour 28

  2. Pharmacokinetic parameter (AUC0-inf)

    Area Under the Curve from time 0 to infinity

    Measured: Hour 0 to hour 28

  3. Pharmacokinetic parameter (AUC0-last)

    Area Under the Curve from time 0 to 28 hrs

    Measured: Hour 0 to hour 28

Secondary outcomes (23)

  1. Pharmacokinetic parameter K

    Terminal Elimination Constant

    Measured: Hour 0 to hour 28

  2. Pharmacokinetic parameter T 1/2

    Half Life

    Measured: Hour 0 to hour 28

  3. Pharmacokinetic parameter T max

    Time of Maximum Concentration

    Measured: Hour 0 to hour 28

  4. Pharmacokinetic parameter T lag

    Lag time

    Measured: Hour 0 to hour 28

  5. Pharmacokinetic parameter Cl/F

    Apparent Clearance

    Measured: Hour 0 to hour 28

  6. Pharmacokinetic parameter Vd/F

    Apparent Volume of Distribution

    Measured: Hour 0 to hour 28

  7. Partial AUC

    Area Under the Curve

    Measured: 0-3 hrs

  8. Partial AUC

    Area Under the Curve

    Measured: 3-6 hrs

  9. Partial AUC

    Area Under the Curve

    Measured: 3-7 hrs

  10. Partial AUC

    Area Under the Curve

    Measured: 6-9 hrs

  11. Partial AUC

    Area Under the Curve

    Measured: 7-12 hrs

  12. Partial AUC

    Area Under the Curve

    Measured: 9-12 hrs

  13. Partial AUC

    Area Under the Curve

    Measured: 12-16 hrs

  14. Safety - ECG

    Evaluation of changes in ECG measurements; heart rate, PR interval, RR interval, QT interval, QTc with Bazett correction, QTc with Fredericia correction intervals, and QRS duration.

    Measured: Day -1 to Day 4

  15. Safety - Vital Signs

    Evaluation of changes in Vital Sign measurements to include blood pressure (mmhg).

    Measured: Day -1 to Day 4

  16. Safety - Vital Signs

    Evaluation of changes in Vital Sign measurements to include weight (kg).

    Measured: Day -1 to Day 4

  17. Safety - Vital Signs

    Evaluation of changes in Vital Sign measurements to include heart rate (bpm).

    Measured: Day -1 to Day 4

  18. Safety - Vital Signs

    Evaluation of changes in Vital Sign measurements to include height (cm).

    Measured: Day -1 to Day 4

  19. Safety - Vital Signs

    Evaluation of Vital Sign measurements to include weight and height combined to report BMI in kg/m^2.

    Measured: Day -1 to Day 4

  20. Safety - Safety Labs

    Evaluation of changes in Safety Lab measurements to include hematology, biochemistry, thyroid, serology, urinalysis, and drugs of abuse.

    Measured: Day -1 to Day 4

  21. Safety - Physical Exam

    Evaluation of changes in the Physical Exam to include general appearance, skin, head, eyes, ears, nose, throat, neck, spine, psychiatric, respiratory, cardiovascular, gastrointestinal, musculoskeletal, central nervous system, lymphatic, endocrine.

    Measured: Day -1 to Day 4

  22. Safety - C-SSRS

    C-SSRS is a tool designed to access and track suicidal adverse events (suicidal behavior and suicidal ideation).

    Measured: Day -1 to Day 4

  23. 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.

  1. First posted12 Aug 2025
  2. Study start31 Oct 2024
  3. Primary completion21 Dec 2024
  4. Study completion27 Dec 2024

Resources

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
25 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07119073
Sponsor's protocol ID
CTx-1301-013
Acronym
Fed-Fast
Status last verified
Apr 2025
First submitted
25 Apr 2025
Last updated
12 Aug 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

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 29 inclusion and 36 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 12 Aug 2025. 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?

On the ClinicalTrials.gov record for NCT07119073.

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 12 Aug 2025.

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