A Study to Assess the Relative Bioavailability of Oral Tavapadon in Healthy Adult Participants

AbbVie

Status and phase: Completed; Phase 1

Conditions: Healthy Volunteer

Treatments: Drug: Tavapadon

Study type: Interventional

Funder types: Industry

Identifiers

NCT06895356

M25-974

Details and patient eligibility

About

This study will assess the relative bioavailability of two different Oral formulations of tavapadon in healthy adult participants.

Enrollment: 83 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Body Mass Index (BMI) ≥ 18.0 to ≤ 32.0 kg/m^2 after rounding to the tenths decimal at the time of screening. BMI is calculated as weight in kg divided by the square of height measured in meters.

• A condition of general good health, based upon the results of a medical history, physical examination, vital signs, laboratory profile, and a 12-lead ECG

• Females, Non-Childbearing Potential due to meeting the following criteria:

  • Permanent sterility due to a hysterectomy, bilateral salpingectomy, bilateral oophorectomy.
  • Non-surgical permanent infertility due to Mullerian agenesis, androgen insensitivity, or gonadal dysgenesis; investigator discretion should be applied to determining study entry.
  • Postmenopausal female who is age ≤ 55 years with no menses for 12 or more months without an alternative medical cause AND a follicle-stimulating hormone (FSH) level ≥ 30 IU/L.

Exclusion criteria

• History of epilepsy, any clinically significant cardiac, respiratory (except mild asthma as a child), renal, hepatic, gastrointestinal, hematologic or psychiatric disease or disorder, or any uncontrolled medical illness.
• History of suicidal ideation within one year prior to study drug administration as evidenced by answering "yes" to questions 4 or 5 on the suicidal ideation portion of the Columbia-Suicide Severity rating scale (C-SSRS) completed at Screening, or any history of suicide attempts within the last two years.
• Use of tobacco- or nicotine-containing products within 90 days prior to the first dose of study treatment.

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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83 participants in 4 patient groups

Tavapadon: Part 1-Sequence 1

Experimental group

Description:

Participants will receive Clinical Tavapadon Dose A in Period 1, followed by Commercial Tavapadon Dose B in Period 2

Treatment:

Drug: Tavapadon

Tavapadon: Part 1-Sequence 2

Experimental group

Description:

Participants will receive Commercial Clinical Tavapadon Dose B in Period 1, followed by Clinical Tavapadon Dose A in Period 2

Treatment:

Drug: Tavapadon

Tavapadon: Part 2-Sequence 1

Experimental group

Description:

Participants will receive Clinical Tavapadon Dose C in Period 1, Clinical Tavapadon Dose D in Period 2 followed by Commercial Tavapadon Dose E in Period 3

Treatment:

Drug: Tavapadon

Tavapadon: Part 2-Sequence 2

Experimental group

Description:

Participants will receive Clinical Tavapadon Dose C in Period 1, Commercial Tavapadon Dose E in Period 2 followed by Clinical Tavapadon Dose D in Period 3

Treatment:

Drug: Tavapadon