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

Overseen ByABBVIE CALL CENTER

Age: 18 - 65

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Recruiting

Sponsor: AbbVie

No Placebo Group

Trial Summary

What is the purpose of this trial?

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

Research Team

ABBVIE INC.

Principal Investigator

AbbVie

Eligibility Criteria

This trial is for healthy adults who are either permanently sterile or postmenopausal women under 55 with no menses for a year and an FSH level ≥ 30 IU/L. Participants must be in good health as determined by medical exams, have a BMI between 18.0 to ≤ 32.0 kg/m2, and cannot be pregnant or breastfeeding.

Inclusion Criteria

Body Mass Index (BMI) must be ≥ 18.0 to ≤ 32.0 kg/m^2 after rounding to the tenths decimal at the time of screening

My overall health is good based on recent medical exams.

I am a woman who cannot have children due to surgery, certain conditions, or being postmenopausal.

Exclusion Criteria

Use of tobacco- or nicotine-containing products within 90 days prior to the first dose of study treatment.

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

I do not have any significant ongoing health issues like heart, lung (except mild childhood asthma), kidney, liver, stomach, blood, or mental health problems.

Treatment Details

Interventions

Tavapadon (Dopamine Agonist)

Trial OverviewThe study is testing the bioavailability (how well the body absorbs) of two different oral formulations of tavapadon—a drug—in healthy adults to see which one works better.

Participant Groups

4Treatment groups

Experimental Treatment

Group I: Tavapadon: Part 2-Sequence 2Experimental Treatment1 Intervention

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

Group II: Tavapadon: Part 2-Sequence 1Experimental Treatment1 Intervention

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

Group III: Tavapadon: Part 1-Sequence 2Experimental Treatment1 Intervention

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

Group IV: Tavapadon: Part 1-Sequence 1Experimental Treatment1 Intervention

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

Find a Clinic Near You

Who Is Running the Clinical Trial?

AbbVie

Lead Sponsor

Trials

1,079

Recruited

535,000+

Founded

2013

Headquarters

North Chicago, USA

Known For

Immunology treatments