Healthy VolunteerPhase 1NCT06895356
A Study to Assess the Relative Bioavailability of Oral Tavapadon in Healthy Adult Participants
A Phase 1 study testing Tavapadon in people with Healthy Volunteer, run by AbbVie at 1 site in United States.
Trial summary
This study will assess the relative bioavailability of two different Oral formulations of tavapadon in healthy adult participants. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteer
- What is being tested?
- Tavapadon
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 83 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Mar 2025to 16 Jun 2025
- Phase
- Phase 1
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
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
This study will assess the relative bioavailability of two different Oral formulations of tavapadon in healthy adult participants.
- Conditions
- Healthy Volunteer
- Being tested
- Tavapadon
- Keywords
- Healthy Volunteer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TavapadonDrug
Oral: Tablet
| Study group | Role | What they receive |
|---|---|---|
| Tavapadon: Part 1-Sequence 1 | Experimental | Participants will receive Clinical Tavapadon Dose A in Period 1, followed by Commercial Tavapadon Dose B in Period 2 Receives: Drug: Tavapadon |
| Tavapadon: Part 1-Sequence 2 | Experimental | Participants will receive Commercial Clinical Tavapadon Dose B in Period 1, followed by Clinical Tavapadon Dose A in Period 2 Receives: Drug: Tavapadon |
| Tavapadon: Part 2-Sequence 1 | Experimental | 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 Receives: Drug: Tavapadon |
| Tavapadon: Part 2-Sequence 2 | Experimental | 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 Receives: Drug: Tavapadon |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants Experiencing Adverse Events
An adverse event is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment
Measured: Up to approximately 53 days
Maximum Observed Plasma Concentration (Cmax) of Tavapadon
(Cmax) of Tavapadon
Measured: Up to approximately 22 days
Time to Cmax (Tmax) of Tavapadon
Tmax of Tavapadon
Measured: Up to approximately 22 days
Apparent Terminal Phase Elimination Rate Constant (β) of Tavapadon
Apparent Terminal Phase Elimination Rate Constant (β) of Tavapadon
Measured: Up to approximately 22 days
Terminal Phase Elimination Half-life (t1/2) of Tavapadon
Terminal Phase Elimination Half-life (t1/2) of Tavapadon
Measured: Up to approximately 22 days
Area Under the Plasma Concentration-time Curve Over the Dosing Interval (AUCτ) of Tavapadon
Area Under the Plasma Concentration-time Curve Over the Dosing Interval (AUCτ) of Tavapadon
Measured: Up to approximately 22 days
Area Under the Plasma Concentration-time Curve from Time Zero to Infinity (AUCinf) of Tavapadon
Area Under the Plasma Concentration-time Curve from Time Zero to Infinity (AUCinf) of Tavapadon
Measured: Up to approximately 22 days
Trough Concentration (Ctrough) of Tavapadon
Trough Concentration (Ctrough) of Tavapadon
Measured: Up to approximately 22 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2025
- Study start26 Mar 2025
- Primary completion16 Jun 2025
- Study completion16 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteerStudies of the same condition, open and under way.
- More trials run by AbbVieThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 83 participants (actual)
Sponsor and investigators
- Lead sponsor
- AbbVie
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- ABBVIE INC., Study director, AbbVie
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06895356
- Sponsor's protocol ID
- M25-974
- Status last verified
- Jun 2025
- First submitted
- 20 Mar 2025
- Last updated
- 26 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No