COMPLETED

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

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

Official Title

A Phase 1, Two Part, Randomized, Single and Multiple Dose Crossover Study to Assess the Relative Bioavailability Between Tavapadon Clinical and Commercial Tablets

Quick Facts

Study Start:2025-03-26

Study Completion:2025-06-16

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:COMPLETED

Study ID

NCT06895356

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 55 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:Yes

Standard Ages:ADULT

Inclusion Criteria	Exclusion 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.	* 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.

Inclusion Criteria

Exclusion 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.

* 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.

Contacts and Locations

Principal Investigator

ABBVIE INC.

STUDY_DIRECTOR

AbbVie

Study Locations (Sites)

Acpru /Id# 275870

Grayslake, Illinois, 60030

United States

Collaborators and Investigators

Sponsor: AbbVie

ABBVIE INC., STUDY_DIRECTOR, AbbVie

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-03-26

Study Completion Date2025-06-16

Study Record Updates

Study Start Date2025-03-26

Study Completion Date2025-06-16

Terms related to this study

Keywords Provided by Researchers

Healthy Volunteer

Additional Relevant MeSH Terms

Healthy Volunteer