83 Participants Needed

Tavapadon Bioavailability Study

AC
Overseen ByABBVIE CALL CENTER
Age: 18 - 65
Sex: Any
Trial Phase: Phase 1
Sponsor: AbbVie
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the study team or your doctor.

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

AI

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.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive different oral formulations of Tavapadon in multiple sequences and periods

22 days

Follow-up

Participants are monitored for safety and effectiveness after treatment

31 days

Treatment Details

Interventions

  • Tavapadon
Trial Overview The 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
Top Products
Humira (adalimumab), Skyrizi (risankizumab), Rinvoq (upadacitinib)

Dr. Roopal Thakkar

AbbVie

Chief Medical Officer since 2023

MD from Wayne State University School of Medicine

Robert A. Michael profile image

Robert A. Michael

AbbVie

Chief Executive Officer

Bachelor's degree in Finance from the University of Illinois

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