CTx-1301 Comparative Bioavailability Study

NCT04138498 | Completed Phase 1 Results FDA Drug

• 1 other identifier: CTx-1301-001
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

Brief 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. In addition, this study seeks to characterize the pharmacokinetics of dexmethylphenidate and evaluate the safety and tolerability of CTx-1301.

Conditions

ADHD

Keywords

ADHD; bioavailability; dexmethylphenidate; BA study; dMPH; d-MPH

Outcome Measures

Primary Outcomes (3)

• Cmax

  d-MPH Plasma concentration

  Hours 0 to 28

• AUC(0-infinity)

  Area under the curve from time 0 extrapolated to infinite time

  Hours 0 to 28

• AUC(Last)

  AUC from time 0 to the last measurable concentration

  Hours 0 to 28

Secondary Outcomes (6)

• Partial AUCs

  Hours 0 to 28

• K

  Hours 0 to 28

• Half-life

  Hours 0 to 28

• Tmax

  Hours 0 to 28

• Tlag

  Hours 0 to 28

Study Arms (4)

Sequence 1 (ADBC)

EXPERIMENTAL

Subjects 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.

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)

EXPERIMENTAL

Subjects 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.

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)

EXPERIMENTAL

Subjects 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.

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)

EXPERIMENTAL

Subjects 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.

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

Interventions

Dexmethylphenidate 5 Mg Oral Capsule, Extended Release DRUG

Reference listed drug (RLD) for comparative BA evaluation

Also known as: Focalin XR (dexmethylphenidate) 5 mg Capsule

Sequence 1 (ADBC); Sequence 2 (BACD); Sequence 3 (CBDA); Sequence 4 (DCAB)

Dexmethylphenidate 6.25 mg Tablet DRUG

Experimental drug for comparative BA evaluation

Also known as: CTx-1301 (dexmethylphenidate) 6.25 mg Tablet

Sequence 1 (ADBC); Sequence 2 (BACD); Sequence 3 (CBDA); Sequence 4 (DCAB)

Dexmethylphenidate 40 Mg Oral Capsule, Extended Release DRUG

Reference listed drug (RLD) for comparative BA evaluation

Also known as: Focalin XR (dexmethylphenidate) 40 mg capsule

Sequence 1 (ADBC); Sequence 2 (BACD); Sequence 3 (CBDA); Sequence 4 (DCAB)

Dexmethylphenidate 50 mg Tablet DRUG

Experimental drug for comparative BA evaluation

Also known as: CTx-1301 (dexmethylphenidate) 50 mg tablet

Sequence 1 (ADBC); Sequence 2 (BACD); Sequence 3 (CBDA); Sequence 4 (DCAB)

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Gender
• a. Male or Female
• Age
• a. Aged between 18 and 55 years inclusive.
• Weight and BMI
• Body weight ≥ 50 kg
• 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

You may not qualify if:

• 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.
• 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
• a. Subject has taken any medication that, in the opinion of an Investigator, has been shown to alter the PK of d-MPH.
• b. 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.

Sponsors & Collaborators

• Cingulate Therapeutics: lead

Study Sites (1)

Vince & Associates

Overland Park, Kansas, 66212, United States

Location

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Interventions

Dexmethylphenidate Hydrochloride; Capsules; Tablets

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Methylphenidate; Phenylacetates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Dosage Forms; Pharmaceutical Preparations

Results Point of Contact

• Title: VP of Clinical Operations and Regulatory Affairs
• Organization: Cingulate Therapeutics

hmitzel@cingulatetherapeutics.com

913-942-2304

Study Officials

• Matt Brams, MD

  Sponsor Medical Officer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 19, 2019
• First Posted: October 24, 2019
• Study Start: December 6, 2019
• Primary Completion: March 6, 2020
• Study Completion: March 6, 2020
• Last Updated: April 8, 2021
• Results First Posted: April 8, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)