Fed-Fast Crossover Study to Assess the Effect of Food With CTx-1301 in Healthy Subjects

NCT04449250 | Completed Phase 1 FDA Drug

• 1 other identifier: CTx-1301-003
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Healthy Volunteers in Fed and Fasted State

Keywords

Healthy Normal Volunteers; Fed Study; Pharmacokinetics; Dexmethylphenidate; Bioavailability; d-MPH; dMPH

Outcome Measures

Primary Outcomes (3)

• Pharmacokinetic parameter (Cmax)

  Maximum Concentration

  Hour 0 to hour 28

• Pharmacokinetic parameter (AUC0-inf)

  Area Under the Curve from time 0 to infinity

  Hour 0 to hour 28

• Pharmacokinetic parameter (AUC0-last)

  Area Under the Curve from time 0 to 28 hrs

  Hour 0 to hour 28

Secondary Outcomes (19)

• Pharmacokinetic parameter K

  Hour 0 to hour 28

• Pharmacokinetic parameter T 1/2

  Hour 0 to hour 28

• Pharmacokinetic parameter T max

  Hour 0 to hour 28

• Pharmacokinetic parameter T lag

  Hour 0 to hour 28

• Pharmacokinetic parameter Cl/F

  Hour 0 to hour 28

Study Arms (2)

CTx-1301 Fasted

ACTIVE COMPARATOR

Subjects will receive CTx-1301 in a fasted state.

Drug: Dexmethylphenidate

CTx-1301 Fed

ACTIVE COMPARATOR

Subjects will receive CTx-1301 in a fed state (high fat test meal).

Drug: Dexmethylphenidate

Interventions

Dexmethylphenidate DRUG

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.

CTx-1301 Fasted; CTx-1301 Fed

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Gender a. Male or Female
• Age
• Aged between 18 and 50 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.
• 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
• 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.

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. 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.
• 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.

Sponsors & Collaborators

• Cingulate Therapeutics: lead

Study Sites (1)

Dr. Vince Clinical Research

Overland Park, Kansas, 66212, United States

Location

MeSH Terms

Conditions

Fasting

Interventions

Dexmethylphenidate Hydrochloride

Condition Hierarchy (Ancestors)

Feeding Behavior; Behavior

Intervention Hierarchy (Ancestors)

Methylphenidate; Phenylacetates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Matt Brams, MD

  Cingulate Therapeutics

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Subjects will be randomized to one of two sequences: Sequence 1) Fasted: Fed or Sequence 2) Fed: Fasted

Study Record Dates

• First Submitted: June 24, 2020
• First Posted: June 26, 2020
• Study Start: September 14, 2022
• Primary Completion: October 14, 2022
• Study Completion: October 14, 2022
• Last Updated: October 20, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)