A Trial to Assess How Centanafadine Interacts With Stimulants in the Body

Otsuka

Status and phase: Not yet enrolling; Phase 1

Conditions: ADHD

Treatments: Drug: Methylphenidate; Drug: Centanafadine; Drug: Lisdexamfetamine

Study type: Interventional

Funder types: Industry

Identifiers

NCT07314333

405-201-00198

Details and patient eligibility

About

This study will look at how centanafadine works when taken together with stimulant medicines in healthy adults, and whether combining them affects how the body responds.

Full description

This is a single dose crossover study. Participants in each arm will receive 3 treatments in a 3 -sequence, 3-period, crossover design. In each arm, participants will be randomized to 1 of 3 treatment sequences: Sequence 1: ABC, Sequence 2: BCA, or Sequence 3: CAB.

Here's what each treatment incudes:

• Treatment A - centanafadine alone in both Arms 1 and 2.
• Treatment B - methylphenidate alone in Arm 1 and lisdexamfetamine alone in Arm 2.
• Treatment C - centanafadine combined with methylphenidate in Arm 1, and centanafadine combined with lisdexamfetamine in Arm 2.

The duration of trial participation for each participant will be approximately 44 days, and the overall trial duration is expected to be approximately 3 months.

Enrollment: 42 estimated patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Body mass index (BMI) between 18.0 to 32.0 kilogram per square meter (kg/m2).

• Must be in good health, based on:

  • Medical history
  • Physical examination
  • Heart test (Electrocardiogram [ECG])
  • Lab tests (blood, urine and other routine checks)

• Willing to stay in the clinic for the required time and agree to a follow-up phone call for safety.

• Able to sign informed consent and, in the investigator's opinion, follow all trial requirements.

Exclusion criteria

• History of drug and/or alcohol abuse in past 2 years.
• History of or current hepatitis or acquired immune deficiency syndrome (AIDS) or carriers of hepatitis B surface antigen (HBsAg) and/or anti-hepatitis C virus (HCV), or human immunodeficiency virus (HIV) antibodies.
• Known drug allergy or hypersensitivity.
• Any history of significant bleeding problems.
• Difficulty donating blood in the past.
• Use of tobacco or exposure to second-hand smoke in the past 2 months, or high cotinine levels in blood/urine.
• Uncontrolled high blood pressure (BP) (systolic blood pressure [SBP] > 140 millimeters of mercury (mmHg) or diastolic blood pressure [DBP] > 90 mmHg) or symptomatic low blood pressure, or orthostatic hypotension (large BP drop when standing).
• History of unexplained fainting (syncope).
• Serious mental health disorders that could interfere with participation.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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42 participants in 6 patient groups

Arm 1, Sequence 1: ABC

Experimental group

Description:

Participants will receive dosing of centanafadine alone (A), once daily (QD) extended release (XR) capsule on Day 1 followed by methylphenidate alone (B), tablet, QD on Day 5, further followed by centanafadine, QD XR capsule along with methylphenidate, tablet (C), QD on Day 9. There will be a washout period of 96 hours between each dosing.

Treatment:

Drug: Centanafadine

Drug: Methylphenidate

Arm 1, Sequence 2: BCA

Experimental group

Description:

Participants will receive dosing of methylphenidate alone (B), tablet, QD on Day 1, followed by centanafadine, QD XR capsule along with methylphenidate, tablet (C), QD on Day 5, further followed by centanafadine alone, QD XR capsule (A) on Day 9. There will be a washout period of 96 hours between each dosing.

Treatment:

Drug: Centanafadine

Drug: Methylphenidate

Arm 1, Sequence 3: CAB

Experimental group

Description:

Participants will receive dosing of centanafadine, QD XR capsule along with methylphenidate, tablet (C), QD on Day 1, followed by centanafadine alone, QD XR capsule (A) on Day 5, further followed by methylphenidate alone, tablet (B), QD on Day 9. There will be a washout period of 96 hours between each dosing.

Treatment:

Drug: Centanafadine

Drug: Methylphenidate

Arm 2, Sequence 1: ABC

Experimental group

Description:

Participants will receive dosing of centanafadine alone, QD XR capsule (A) on Day 1 followed by lisdexamfetamine alone, capsule (B), QD on Day 5, further followed by centanafadine, QD XR capsule along with lisdexamfetamine, capsule (C), QD on Day 9. There will be a washout period of 96 hours between each dosing.

Treatment:

Drug: Lisdexamfetamine

Drug: Centanafadine

Arm 2, Sequence 2: BCA

Experimental group

Description:

Participants will receive dosing of lisdexamfetamine alone, capsule (B), QD on Day 1, followed by centanafadine, QD XR capsule along with lisdexamfetamine, capsule (C), QD on Day 5, further followed by centanafadine alone, QD XR capsule (A) on Day 9. There will be a washout period of 96 hours between each dosing.

Treatment:

Drug: Lisdexamfetamine

Drug: Centanafadine

Arm 2, Sequence 3: CAB

Experimental group

Description:

Participants will receive dosing of centanafadine, QD XR capsule along with lisdexamfetamine, capsule (C), QD on Day 1, followed by centanafadine alone, QD XR capsule (A) on Day 5, further followed by lisdexamfetamine alone, capsule (B), QD on Day 9. There will be a washout period of 96 hours between each dosing.

Treatment:

Drug: Lisdexamfetamine

Drug: Centanafadine