AzTrials
AzTrials

ADHDPhase 1/2NCT04138498

CTx-1301 Comparative Bioavailability Study

A Phase 1/2 study testing Dexmethylphenidate 5 Mg Oral Capsule, Extended Release, Dexmethylphenidate 6.25 mg Tablet and Dexmethylphenidate 40 Mg Oral Capsule, Extended Release in people with ADHD, 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 compare the bioavailability of CTx-1301 (dexmethylphenidate) to the registered listed drug, Focalin XR and to evaluate dose proportionality of CTx-1301. Read more about this study

Who is it for?
Ages 18 to 55 years
Conditions the study is for
ADHD
What is being tested?
Dexmethylphenidate 5 Mg Oral Capsule, Extended Release, Dexmethylphenidate 6.25 mg Tablet and Dexmethylphenidate 40 Mg Oral Capsule, Extended Release
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
45 participants
Where
1 siteUnited States
Study dates
6 Dec 2019to 6 Mar 2020
Phase
Phase 1/2
Are there results?
Yes, posted in the registrySummary in the doctors' view

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
  • No healthy volunteers
  • Adult

Who may be able to join

  • Gender
  • Male or Female
  • Age
  • Aged between 18 and 55 years inclusive.
  • Weight and BMI
  • Body weight ≥ 50 kg
Show all 29Show fewer
  • BMI ≥ 18 and ≤ 35
  • Compliance
  • Understands and is willing, able and likely to comply with all study procedures and restrictions.
  • If sexually active, male subjects must use the double-barrier method (condom and spermicide) for birth control 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, including abstinence from heterosexual intercourse, hormonal contraceptives, intrauterine device (IUD) with or without hormones, or double-barrier method (e.g. condom and spermicide), 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 a. 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.
  • Indication
  • Subject must report history of diagnosis of ADHD.
  • If subject is currently taking stimulant medication, they must be willing and able to safely abstain from any other ADHD treatment during 96 hrs. prior to check-in on Day -4 and through the complete duration of the study.
  • 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 study data.
  • No vomiting or fever within 24-hours of check-in at Day -4
  • Subject has sufficient venous access to allow cannulation and/or venipuncture to obtain the required volume of blood for this study.
  • Subject must currently be taking or previously have taken a stimulant medication for ADHD.
  • Smoking/Caffeine/Alcohol
  • Subject must be able to refrain from smoking cigarettes 1 hour prior to dosing and 7 hours after dosing on dosing days. Subject must agree not to smoke more than one cigarette per hour, not to exceed 10 cigarettes per day.
  • Subject must be able to refrain from caffeine for 10 hours prior to check-in at Day -4 and for the duration of the study.
  • Subject must be able to refrain from using alcohol 48 hrs. prior to Day -4 and for the duration of the study.
  • ADHD Medication History
  • Subject's medication history suggests they will be able to tolerate a 40 mg dose of dexmethylphenidate.
  • Subject must demonstrate tolerability of dexmethylphenidate assessed by tolerability day/test dose of 40 mg Focalin XR as evaluated by the 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, 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. 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.
Show all 32Show fewer
  • 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.
  • As a result of the MINI, medical history, physical examination, and/or screening investigations (including ECG results, vital signs and/or laboratory abnormality), an Investigator considers the subject disqualified for 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 of the study.
  • 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 -3 (ADHD medications must be discontinued at least 96 hours prior to check-in at Day -4), and/or use of any OTC medications (such as antacids, vitamins, minerals, dietary/herbal preparations, and nutritional supplements) within 7 days prior to Day -3 unless jointly approved by an Investigator and Sponsor.
  • Subjects are permitted to take hormonal contraceptives and hormone replacement therapy at acceptable levels if stable at least 30 days prior to Day -4, 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.
  • 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 (eg, topical medications).
  • Alcohol/Substance Abuse
  • Recent history (within the last year) of alcohol or other substance abuse.
  • Subject has positive breath alcohol test or urine test for drugs of abuse at screening or check-in (prescribed ADHD medication is acceptable during screening but must be stopped at least 96 hrs prior to check in at Day -4). Note: At the discretion of an Investigator, the tests may be repeated. If THC is positive at screening or check-in, a cannabis intoxication evaluation will be done by an investigator at check-in only; inclusion will be at the investigator's discretion, due to the slow release of THC from adipose tissue.
  • Smoking
  • Subject regularly smokes more than 10 cigarettes/day (or other nicotine-containing products) or Subject has recently discontinued smoking (within the last 3 months)
  • 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
  • Participation in another investigational product study (inclusive of final post-study examination) or receipt of an investigational drug within the 30 days before screening day.
  • Previous participation in this study.
  • Personnel
  • An employee of the sponsor, study site, or members of their immediate family.
  • Blood
  • Subject has donated blood, plasma, or experienced significant blood loss (excess of 500 ml) within 3 months of screening and for the duration of the study.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Vince & Associates

    Overland Park, Kansas, 66212

Other trials in United States

About this study

Official title: A Randomized, Single-dose, Four-sequence, Four-period, Crossover Study in Adult ADHD Subjects to Establish Safety, Tolerability, and Comparative Bioavailability of CTx-1301 (Dexmethylphenidate) to Focalin XR™ Under Fasted Conditions

The primary purpose of this study is to compare the bioavailability of CTx-1301 (dexmethylphenidate) to the registered listed drug, Focalin XR and to evaluate dose proportionality of CTx-1301. In addition, this study seeks to characterize the pharmacokinetics of dexmethylphenidate and evaluate the safety and tolerability of CTx-1301.

Read the detailed description

The study will comprise of a randomized, single-dose, four-sequence, four-period, in-clinic crossover study in approximately 36 adult ADHD subjects. All subjects considered eligible at Screening will proceed to tolerability test day, dosing 40 mg Focalin XR to evaluate safety and tolerability of the higher dose of d-MPH. If subject is able to safely tolerate the test dose, and meets all inclusion/exclusion criteria, they will be considered eligible for randomization into the study. All subjects will be randomized to receive four treatments throughout the course of the study; one CTx-1301 trimodal d-MPH tablet containing 6.25 mg d-MPH, one Focalin 5 mg XR capsule, one CTx-1301 50 mg tablet, and one 40 mg Focalin XR capsule. Administration of study drug will occur only on Assessment Days; no study drug will be administered during screening or unscheduled days (USVs).

The lowest and highest doses of CTx-1301 (dexmethylphenidate, 6.25 and 50 mg) were selected to bridge to the lowest and highest doses of Focalin XR (dexmethylphenidate, 5 and 40 mg) in this comparative BA study.

Conditions
ADHD
Being tested
Dexmethylphenidate 5 Mg Oral Capsule, Extended Release, Dexmethylphenidate 6.25 mg Tablet, Dexmethylphenidate 40 Mg Oral Capsule, Extended Release, Dexmethylphenidate 50 mg Tablet
Keywords
ADHD, bioavailability, dexmethylphenidate, BA study, dMPH, d-MPH
Medical subject headings
Attention Deficit Disorder with Hyperactivity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Dexmethylphenidate 5 Mg Oral Capsule, Extended ReleaseDrug

    Also called Focalin XR (dexmethylphenidate) 5 mg Capsule

    Reference listed drug (RLD) for comparative BA evaluation

  • Dexmethylphenidate 6.25 mg TabletDrug

    Also called CTx-1301 (dexmethylphenidate) 6.25 mg Tablet

    Experimental drug for comparative BA evaluation

  • Dexmethylphenidate 40 Mg Oral Capsule, Extended ReleaseDrug

    Also called Focalin XR (dexmethylphenidate) 40 mg capsule

    Reference listed drug (RLD) for comparative BA evaluation

  • Dexmethylphenidate 50 mg TabletDrug

    Also called CTx-1301 (dexmethylphenidate) 50 mg tablet

    Experimental drug for comparative BA evaluation

Study groups in NCT04138498
Study groupRoleWhat they receive
Sequence 1 (ADBC)ExperimentalSubjects in sequence ADBC will receive study treatments in the following order: Focalin XR 5 mg capsule, CTx-1301 50 mg tablet, CTx-1301 6.25 mg tablet, Focalin XR 40 mg capsule.
Receives: Drug: Dexmethylphenidate 5 Mg Oral Capsule, Extended Release; Drug: Dexmethylphenidate 6.25 mg Tablet; Drug: Dexmethylphenidate 40 Mg Oral Capsule, Extended Release; Drug: Dexmethylphenidate 50 mg Tablet
Sequence 2 (BACD)ExperimentalSubjects in sequence BACD will receive study treatments in the following order: CTx-1301 6.25 mg tablet, Focalin XR 5 mg capsule, Focalin XR 40 mg capsule, CTx-1301 50 mg tablet.
Receives: Drug: Dexmethylphenidate 5 Mg Oral Capsule, Extended Release; Drug: Dexmethylphenidate 6.25 mg Tablet; Drug: Dexmethylphenidate 40 Mg Oral Capsule, Extended Release; Drug: Dexmethylphenidate 50 mg Tablet
Sequence 3 (CBDA)ExperimentalSubjects in sequence CBDA will receive study treatments in the following order: Focalin XR 40 mg capsule, CTx-1301 6.25 mg tablet, CTx-1301 50 mg tablet, Focalin XR 5 mg capsule.
Receives: Drug: Dexmethylphenidate 5 Mg Oral Capsule, Extended Release; Drug: Dexmethylphenidate 6.25 mg Tablet; Drug: Dexmethylphenidate 40 Mg Oral Capsule, Extended Release; Drug: Dexmethylphenidate 50 mg Tablet
Sequence 4 (DCAB)ExperimentalSubjects in sequence DCAB will receive study treatments in the following order: CTx-1301 50 mg tablet, Focalin XR 40 mg capsule, Focalin XR 5 mg capsule, CTx-1301 6.25 mg tablet.
Receives: Drug: Dexmethylphenidate 5 Mg Oral Capsule, Extended Release; Drug: Dexmethylphenidate 6.25 mg Tablet; Drug: Dexmethylphenidate 40 Mg Oral Capsule, Extended Release; Drug: Dexmethylphenidate 50 mg Tablet

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Cmax

    d-MPH Plasma concentration

    Measured: Hours 0 to 28

  2. AUC(0-infinity)

    Area under the curve from time 0 extrapolated to infinite time

    Measured: Hours 0 to 28

  3. AUC(Last)

    AUC from time 0 to the last measurable concentration

    Measured: Hours 0 to 28

Secondary outcomes (6)

  1. Partial AUCs

    AUC from Hours 0-3, 3-6, 6-9, 9-12, and 12 to 16

    Measured: Hours 0 to 28

  2. K

    Rate at which a drug is removed from the system

    Measured: Hours 0 to 28

  3. Half-life

    Time (Hours) it takes for the concentration of the drug in plasma to be reduced by 50%

    Measured: Hours 0 to 28

  4. Tmax

    Time (Hours) after administration of a drug when the maximum plasma concentration is reached

    Measured: Hours 0 to 28

  5. Tlag

    Delay (hours) between the time of dosing and time of appearance of concentration in the sampling

    Measured: Hours 0 to 28

  6. Incidence of Treatment-Emergent Adverse Events

    TEAEs will be measured from Day 0 to Day 10 (End of Study)

    Measured: Day 0 to Day 10

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Oct 2019
  2. Study start6 Dec 2019
  3. Primary completion6 Mar 2020
  4. Study completion6 Mar 2020

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 1/2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Crossover
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
45 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04138498
Sponsor's protocol ID
CTx-1301-001
Status last verified
Mar 2021
First submitted
19 Sep 2019
Last updated
8 Apr 2021
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • Straughn AB, Silva R, Cattaneo MJ, Koehn K, Brams M. Comparative Bioavailability of Trimodal (CTx-1301) Versus Bimodal Dexmethylphenidate Modified-Release Formulations in Adults with Attention-Deficit/Hyperactivity Disorder: A Randomized, Single-Dose, Crossover Study. CNS Drugs. 2026 Jul 28. doi: 10.1007/s40263-026-01319-3. Online ahead of print.

    PubMed 42518155

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Dexmethylphenidate 5 Mg Oral Capsule, Extended Release, Dexmethylphenidate 6.25 mg Tablet and Dexmethylphenidate 40 Mg Oral Capsule, Extended Release in people with ADHD, 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 32 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 8 Apr 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 combined 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.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 8 Apr 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Cmax (time frame: Hours 0 to 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 NCT04138498, which also lists 1 linked publication.

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 8 Apr 2021.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free AzTrials account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in