A Phase 1 interventional study of TAK-831 in Healthy Volunteers, sponsored by Neurocrine Biosciences. Completed at 1 site in United States. Open to participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-06-14.
Sponsored by Neurocrine Biosciences · Phase 1, Interventional, and Other
The purpose of this study is to determine the pharmacokinetic (PK) of a single oral dose of TAK-831 400 milligram (mg) in the fasted state and to estimate the effect of food on the PK of a single oral dose of TAK-831 400 mg when administered as tablet formulation in healthy participants.
The drug being tested in this study is called TAK-831. TAK-831 is being tested in healthy participants under fasting and fed conditions in order to determine the effect of food on the PK of single oral dose of TAK-831 tablet formulation. The study will enroll approximately 16 participants. Participants will be randomly and equally assigned (by chance, like flipping a coin) to 1 of the 2 treatment sequences following as:
Neurocrine Biosciences is the lead sponsor of 85 studies on the registry; 16 are open to participants now.
Of its 35 completed or terminated interventional studies of FDA-regulated products, 23 (66%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
TAK-831 400 mg, film-coated tablets, orally under fasted state, once on Day 1 of Intervention Period 1, followed by 7 days washout period, further followed by TAK-831 400 mg, film-coated tablets, orally under fed state, once on Day 1 of Intervention Period 2.
Drug: TAK-831
TAK-831 400 mg, film-coated tablets, orally under fed state, once on Day 1 of Intervention Period 1, followed by 7 days washout period, further followed by TAK-831 400 mg, film-coated tablets, orally under fasted state, once on Day 1 of Intervention Period 2.
Drug: TAK-831
TAK-831 film-coated tablet.
Cmax: Maximum Observed Plasma Concentration for TAK-831
Time frame: Day 1 pre-dose and at multiple time points (up to 72 hours) post-dose
AUClast: Area Under the Plasma Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration for TAK-831
Time frame: Day 1 pre-dose and at multiple time points (up to 72 hours) post-dose
AUC∞: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for TAK-831
Time frame: Day 1 pre-dose and at multiple time points (up to 72 hours) post-dose
Percentage of Participants Who Experience at Least 1 Treatment-emergent Adverse Event (TEAE)
Time frame: Day 1
Participants took part in the study at 1 investigative site in the United States from 04 April 2017 to 26 May 2017.
| Milestone | TAK-831 400 mg Fasted + TAK-831 400 mg Fed | TAK-831 400 mg Fed + TAK-831 400 mg Fasted |
|---|---|---|
| Started | 7 | 8 |
| Completed | 7 | 8 |
| Not completed | 0 | 0 |
| Milestone | TAK-831 400 mg Fasted + TAK-831 400 mg Fed | TAK-831 400 mg Fed + TAK-831 400 mg Fasted |
|---|---|---|
| Started | 7 | 8 |
| Completed | 6 | 8 |
| Not completed | 1 | 0 |
| Withdrew: Positive drug urine screen | 1 | 0 |
| Milestone | TAK-831 400 mg Fasted + TAK-831 400 mg Fed | TAK-831 400 mg Fed + TAK-831 400 mg Fasted |
|---|---|---|
| Started | 6 | 8 |
| Completed | 6 | 8 |
| Not completed | 0 | 0 |
| nanogram per milliliter (ng/mL) | TAK-831 400 mg Fasted | TAK-831 400 mg Fed |
|---|---|---|
| Cmax: Maximum Observed Plasma Concentration for TAK-831 | 650.04 ± 47.7 | 865.48 ± 53.5 |
| hour*nanogram per milliliter (h*ng/mL) | TAK-831 400 mg Fasted | TAK-831 400 mg Fed |
|---|---|---|
| AUClast: Area Under the Plasma Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration for TAK-831 | 2290.8 ± 53.1 | 2535.6 ± 58.8 |
| h*ng/mL | TAK-831 400 mg Fasted | TAK-831 400 mg Fed |
|---|---|---|
| AUC∞: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for TAK-831 | 2194.8 ± 53.1 | 2465.9 ± 67.8 |
| percentage of participants | TAK-831 400 mg Fasted | TAK-831 400 mg Fed |
|---|---|---|
| Percentage of Participants Who Experience at Least 1 Treatment-emergent Adverse Event (TEAE) | 0 | 7.1 |
Collected over Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 14 days after the last dose of study drug (up to Day 23). Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| TAK-831 400 mg Fasted | 0/15 (0%) | 0/15 (0%) | 0/15 (0%) |
| TAK-831 400 mg Fed | 0/14 (0%) | 0/14 (0%) | 1/14 (7.1%) |
| Event | TAK-831 400 mg Fasted | TAK-831 400 mg Fed |
|---|---|---|
| Upper respiratory tract infectionInfections and infestations | 0/15 | 1/14 |
The safety analysis set included all participants who were randomized and received at least 1 dose of study drug.
| Age, Continuous(years) | TAK-831 400 mg Fasted + TAK-831 400 mg Fed | TAK-831 400 mg Fed + TAK-831 400 mg Fasted | Total |
|---|---|---|---|
| Mean | 35.4 ± 7.98 | 32.6 ± 11.22 | 33.9 ± 9.61 |
| Sex: Female, Male(Participants) | TAK-831 400 mg Fasted + TAK-831 400 mg Fed | TAK-831 400 mg Fed + TAK-831 400 mg Fasted | Total |
|---|---|---|---|
| Female | 1 | 2 | 3 |
| Male | 6 | 6 | 12 |
| Ethnicity (NIH/OMB)(Participants) | TAK-831 400 mg Fasted + TAK-831 400 mg Fed | TAK-831 400 mg Fed + TAK-831 400 mg Fasted | Total |
|---|---|---|---|
| Hispanic or Latino | 1 | 0 | 1 |
| Not Hispanic or Latino | 6 | 8 | 14 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | TAK-831 400 mg Fasted + TAK-831 400 mg Fed | TAK-831 400 mg Fed + TAK-831 400 mg Fasted | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 1 | 0 | 1 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 3 | 3 | 6 |
| White | 3 | 5 | 8 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Region of Enrollment(Participants) | TAK-831 400 mg Fasted + TAK-831 400 mg Fed | TAK-831 400 mg Fed + TAK-831 400 mg Fasted | Total |
|---|---|---|---|
| United States | 7 | 8 | 15 |
| Weight(kilogram (kg)) | TAK-831 400 mg Fasted + TAK-831 400 mg Fed | TAK-831 400 mg Fed + TAK-831 400 mg Fasted | Total |
|---|---|---|---|
| Mean | 73.3 ± 9.65 | 78.6 ± 11.19 | 76.1 ± 10.48 |
| Height(centimeter (cm)) | TAK-831 400 mg Fasted + TAK-831 400 mg Fed | TAK-831 400 mg Fed + TAK-831 400 mg Fasted | Total |
|---|---|---|---|
| Mean | 171.3 ± 6.40 | 173.8 ± 7.19 | 172.6 ± 6.71 |
| Body Mass Index (BMI)(kilogram per square meter (kg/m^2)) | TAK-831 400 mg Fasted + TAK-831 400 mg Fed | TAK-831 400 mg Fed + TAK-831 400 mg Fasted | Total |
|---|---|---|---|
| Mean | 24.9 ± 2.17 | 25.9 ± 2.45 | 25.5 ± 2.30 |
5 further baseline measures are reported on the registry.
Documents are hosted by the registry — open the source record to download them.
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