Healthy VolunteersPhase 1NCT04992442
Study to Assess Absolute Bioavailability of TAK-935 (OV935) and to Characterize Mass Balance, Pharmacokinetics, Metabolism, and Excretion of [14C]TAK-935 (OV935) in Healthy Male Participants
A Phase 1 study testing TAK-935 Oral Tablet, [14C]TAK-935 IV Infusion and [14C]TAK-935 Oral Solution in people with Healthy Volunteers, run by Takeda at 1 site in United States.
Trial summary
The purpose of this study is to determine absolute bioavailability (ABA) of TAK-935 (F) following a single microdose intravenous (IV) administration of 50 microgram (μg) (approximately 1 microcurie [μCi]) [14C]TAK-935 and a single oral administration of 3×100 mg milligram (mg) TAK-935 tablets in Treatment Period 1… Read more about this study
- Who is it for?
- Ages 19 to 55 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- TAK-935 Oral Tablet, [14C]TAK-935 IV Infusion and [14C]TAK-935 Oral Solution
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Jul 2020to 18 Aug 2020
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 19 to 55 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Weighs at least 50 kg and body mass index (BMI) ≥18.0 and ˂32.0 kg/m^2 at Screening Visit.
- Continuous nonsmoker who has not used nicotine-containing products (including vaping) for at least 3 months prior to the first dosing and throughout the study, based on participant self-reporting.
- Medically healthy with no clinically significant medical history, physical examination, laboratory profiles, vital signs or ECGs, as deemed by the Investigator or designee.
Who cannot join
- History or presence of cataracts or other clinically significant vision disturbances.
- Abnormal and clinically significant ECG abnormality at Screening visit:
- QT interval with Fridericia's correction method (QTcF) >450 milliseconds (ms) confirmed with one repeat testing.
- History or presence of gastritis, gastrointestinal tract, gastric bypass surgery, or hepatic disorder or other clinical condition which, in the opinion of the Investigator or designee, may affect the absorption, distribution, metabolism, or elimination of study drug.
- Has a risk of suicide according to the Investigator's clinical judgment [e.g., per Columbia-Suicide Severity Rating Scale (C-SSRS)] or has made a suicide attempt in the previous year prior to Screening Visit.
- Positive urine drug or alcohol results at screening or first check-in.
Show all 21Show fewer
- Positive results at screening for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV) or novel coronavirus 2019 (COVID-19).
- Seated blood pressure is less than 90/40 millimeter of mercury (mmHg) or greater than 140/90 mmHg at Screening.
- Seated HR is lower than 40 beats per minute (bpm) or higher than 99 bpm at Screening Visit.
- Estimated creatinine clearance <80 mL/min at Screening Visit.
- Has tattoo(s) or scarring at or near the site of IV infusion or any other condition which may interfere with infusion site examination, in the opinion of the Investigator.
- Has infrequent bowel movements (less than approximately once per day) within 30 days prior to first dosing.
- Recent history of abnormal bowel movements, such as diarrhea, loose stools, or constipation, within 2 weeks prior to first dosing.
- Has received radiolabeled substances or has been exposed to radiation sources within 12 months of first dosing or is likely to receive radiation exposure or radioisotopes within 12 months of first dosing such that participation in this study would increase their total exposure beyond the recommended levels considered safe [i.e., weighted annual limit recommended by the International Commission on Radiological Protection (ICRP) of 3000 milli roentgen equivalent man (mrem)].
- Unable to refrain from or anticipates the use of:
- Any drug, including prescription and nonprescription medications, herbal remedies, or vitamin supplements within 14 days prior to the first dosing and throughout the study, including the Follow-up Period. Thyroid hormone replacement medication may be permitted if the participant has been on the same stable dose for the immediate 3 months prior to first study drug administration. After the first dose of study drug, ibuprofen (up to 1.2 g per 24 hours) may be administered at the discretion of the Investigator or designee. Milk of Magnesia (i.e., magnesium hydroxide) (≤60 mL per day) may be administered to ensure defecation, at discretion of the Investigator or designee.
- Any drugs known to be significant inducers of cytochrome P450 (CYP)3A4, CYP2C19 or uridine diphosphate glucuronosyltransferase (UGT), including St. John's Wort, within 28 days prior to the first dosing and throughout the study, including the Follow-up Period. Appropriate sources (e.g., Flockhart Table^TM) will be consulted to confirm lack of PK/pharmacodynamic interaction with study drug(s).
- Alcohol
- Has been on a diet incompatible with the on-study diet, in the opinion of the Investigator or designee, within the 30 days prior to the first dosing and throughout the study.
- Donation of blood or significant blood loss within 56 days prior to the first dosing.
- Plasma donation within 7 days prior to the first dosing.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1 Study to Assess Absolute Bioavailability of TAK-935 (OV935) and to Characterize Mass Balance, Pharmacokinetics, Metabolism, and Excretion of [14C]TAK-935 (OV935) in Healthy Adult Male Participants
The purpose of this study is to determine absolute bioavailability (ABA) of TAK-935 (F) following a single microdose intravenous (IV) administration of 50 microgram (μg) (approximately 1 microcurie [μCi]) [14C]TAK-935 and a single oral administration of 3×100 mg milligram (mg) TAK-935 tablets in Treatment Period 1, and to assess the mass balance, characterize the pharmacokinetics (PK) of TAK-935 and metabolite [M-I (N-oxide)] in plasma and urine, and total radioactivity concentration equivalents in plasma and whole blood following a single oral administration of 300 mg (approximately 100 μCi) [14C]TAK-935 in Treatment Period 2.
Read the detailed description
The drug being tested in this study is called TAK-935 (also known as soticlestat/OV935). The study determines ABA in Treatment Period 1, and the absorption, metabolism, excretion, and mass balance of TAK-935 after single oral administration in Treatment Period 2 in healthy adult male participants, by collecting plasma, urine, and feces samples for drug concentration analysis, and plasma, whole blood, urine, and fecal samples for total radioactivity analysis and metabolic profiling.
The study will enroll approximately 6 healthy adult male participants. The study is designed to consist of 2 periods: Treatment Period 1 (ABA Study Period) and Treatment Period 2 (Absorption, Distribution, Metabolism, and Elimination [ADME] Study Period). In Treatment Period 1, all participants will receive a single unlabelled oral dose of TAK-935 as 3×100 mg tablets and a microdose IV infusion of 50 μg (approximately 1 μCi) [14C]TAK-935, followed by a Washout Period of 7 days before the dose in Treatment Period 2. In Treatment Period 2, all participants will receive a single dose of 300 mg (approximately 100 μCi) [14C]TAK-935 as an oral solution.
This single center trial will be conducted in the United States. The overall time to participate in this study is approximately 65 days including Screening Period. Participants will be contacted approximately 30 days after the last dose of study drug for a follow-up assessment. This compound was transferred to Takeda and acquired on 29 March 2021. This registration is retrospective due to the transfer of ownership.
- Conditions
- Healthy Volunteers
- Being tested
- TAK-935 Oral Tablet, [14C]TAK-935 IV Infusion, [14C]TAK-935 Oral Solution
- Keywords
- Drug Therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TAK-935 Oral TabletDrug
Also called OV935, Soticlestat
TAK-935 tablet
[14C]TAK-935 IV InfusionDrug
Also called OV935
[14C]TAK-935 IV infusion
[14C]TAK-935 Oral SolutionDrug
Also called OV935
[14C]TAK-935 oral solution
| Study group | Role | What they receive |
|---|---|---|
| TAK-935 300 mg + [14C]TAK-935 50 μg + [14C]TAK-935 300 mg | Experimental | TAK-935 3×100 mg, tablets, orally, once on Day 1, followed by [14C]TAK-935 50 micrograms (μg) [approximately 1 μCi], IV infusion, once on Day 1 of Treatment Period 1, followed by a Washout Period of 7 days, further followed by [14C]TAK-935 300 mg (approximately 100 μCi) solution, orally, once on Day 1 of Treatment Period 2. Receives: Drug: TAK-935 Oral Tablet; Drug: [14C]TAK-935 IV Infusion; Drug: [14C]TAK-935 Oral Solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
Period 1: Percent Absolute Bioavailability (%F) for TAK-935
Bioavailability is defined as the proportion of a drug which enters the circulation when introduced into the body and so is able to have an active effect. Percent absolute bioavailability, calculated for plasma TAK-935 as [Actual Dose (IV) x Area Under the Concentration-time Curve from Time 0 to Infinity {AUCinf} (oral)] / [Actual Dose (oral) x AUCinf (IV)] x 100.
Measured: Day 1 pre-dose and at multiple time points (up to 48 hours) post-dose in Treatment Period 1
Period 2: Total Radioactivity Expressed as Cumulative Percentage of Dose of [14C]TAK-935 Excreted in Urine and Feces Combined [Combined Cum%Dose]
Measured: Day 1 pre-dose and at multiple time points (up to 120 hours) post-dose in Treatment Period 2
Period 2: Total Radioactivity Expressed as Amount of [14C]TAK-935 Excreted in Urine (CumAe[u])
Measured: Day 1 pre-dose and at multiple time points (up to 120 hours) post-dose in Treatment Period 2
Period 2: Total Radioactivity Expressed as Amount of [14C]TAK-935 Excreted in Feces (CumAe[f])
Measured: Day 1 pre-dose and at multiple time points (up to 120 hours) post-dose in Treatment Period 2
Period 2: Total Radioactivity Expressed as Amount of [14C]TAK-935 Excreted in Urine and Feces Combined (Combined CumAe)
Measured: Day 1 pre-dose and at multiple time points (up to 120 hours) post-dose in Treatment Period 2
Period 2: Percentage of Administered Radioactive Dose of [14C]TAK-935 Excreted in Urine (Cum%Dose[u])
Measured: Day 1 pre-dose and at multiple time points (up to 120 hours) post-dose in Treatment Period 2
Period 2: Percentage of Administered Radioactive Dose of [14C]TAK-935 Excreted in Feces (Cum%Dose[f])
Measured: Day 1 pre-dose and at multiple time points (up to 120 hours) post-dose in Treatment Period 2
Period 2: Cmax: Maximum Observed Plasma Concentration of TAK-935
Measured: Day 1 pre-dose and at multiple time points (up to 120 hours) post-dose in Treatment Period 2
Period 2: Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) of TAK-935
Measured: Day 1 pre-dose and at multiple time points (up to 120 hours) post-dose in Treatment Period 2
Period 2: t(1/2)z: Terminal Disposition Phase Half-life of TAK-935 in Plasma
Measured: Day 1 pre-dose and at multiple time points (up to 120 hours) post-dose in Treatment Period 2
Period 2: AUC0-inf: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity of TAK-935
Measured: Day 1 pre-dose and at multiple time points (up to 120 hours) post-dose in Treatment Period 2
Period 2: AUC0-t: Area Under the Plasma Concentration-time Curve From Time 0 to Time t for TAK-935
Measured: Day 1 pre-dose and at multiple time points (up to 120 hours) post-dose in Treatment Period 2
Period 2: AUC0-last: Area Under the Plasma Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration of TAK-935
Measured: Day 1 pre-dose and at multiple time points (up to 120 hours) post-dose in Treatment Period 2
Period 2: Cmax: Maximum Observed Plasma Radioactivity Concentration
Measured: Day 1 pre-dose and at multiple time points (up to 120 hours) post-dose in Treatment Period 2
Period 2: Tmax: Time to Reach the Maximum Plasma Radioactivity Concentration (Cmax)
Measured: Day 1 pre-dose and at multiple time points (up to 120 hours) post-dose in Treatment Period 2
Period 2: t(1/2)z: Terminal Disposition Phase Half-life of Plasma Radioactivity Concentration
Measured: Day 1 pre-dose and at multiple time points (up to 120 hours) post-dose in Treatment Period 2
Period 2: AUC0-inf: Area Under the Plasma Radioactivity Concentration-time Curve From Time 0 to Infinity
Measured: Day 1 pre-dose and at multiple time points (up to 120 hours) post-dose in Treatment Period 2
Period 2: AUC0-t: Area Under the Plasma Radioactivity Concentration-time Curve From Time 0 to Time t
Measured: Day 1 pre-dose and at multiple time points (up to 120 hours) post-dose in Treatment Period 2
Period 2: AUC0-last: Area Under the Plasma Radioactivity Concentration-time Curve From Time 0 to Last Quantifiable Concentration
Measured: Day 1 pre-dose and at multiple time points (up to 120 hours) post-dose in Treatment Period 2
Period 2: Cmax: Maximum Observed Whole Blood Radioactivity Concentration
Measured: Day 1 pre-dose and at multiple time points (up to 120 hours) post-dose in Treatment Period 2
Period 2: Tmax: Time to Reach the Maximum Whole Blood Radioactivity Concentration (Cmax)
Measured: Day 1 pre-dose and at multiple time points (up to 120 hours) post-dose in Treatment Period 2
Period 2: t(1/2)z: Terminal Disposition Phase Half-life of Whole Blood Radioactivity Concentration
Measured: Day 1 pre-dose and at multiple time points (up to 120 hours) post-dose in Treatment Period 2
Period 2: AUC0-inf: Area Under the Whole Blood Radioactivity Concentration-time Curve From Time 0 to Infinity
Measured: Day 1 pre-dose and at multiple time points (up to 120 hours) post-dose in Treatment Period 2
Period 2: AUC0-t: Area Under the Whole Blood Radioactivity Concentration-time Curve From Time 0 to t
Measured: Day 1 pre-dose and at multiple time points (up to 120 hours) post-dose in Treatment Period 2
Period 2: AUC0-last: Area Under the Whole Blood Radioactivity Concentration-time Curve From Time 0 to Last Quantifiable Concentration
Measured: Day 1 pre-dose and at multiple time points (up to 120 hours) post-dose in Treatment Period 2
Period 2: CLR: Renal Clearance for TAK-935 in Urine
Renal clearance (CLr) is the volume of plasma entering the kidney that is completely cleared of drug per unit of time.
Measured: Day 1 pre-dose and at multiple time points (up to 120 hours) post-dose in Treatment Period 2
Period 2: Aet1-t2: Amount of TAK-935 Excreted in the Urine in Each Collection Interval
Measured: 0-12, 12-24, 24-48, 48-72, 72-96, 96-120 hours post-dose in Treatment Period 2
Period 2: Whole Blood to Plasma Partitioning Ratio: Change From Baseline in Percentage of [14C]TAK-935 Radioactivity in Whole Blood Relative to Plasma
Measured: 0.17, 0.42, 0.75, 1.5, 2.5, 4.5, 8, 12, and 24 hours post-dose in Treatment Period 2
Secondary outcomes (22)
Period 1: Ceoi: Plasma Concentration at the End of Infusion for [14C]TAK-935
Measured: Day 1: At the end of infusion (at 15 minutes post dose) in Treatment Period 1
Period 1: Cmax: Maximum Observed Plasma Concentration for TAK-935 After Oral Administration
Measured: Day 1 pre-dose and at multiple time points (up to 48 hours) post-dose in Treatment Period 1
Period 1: Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for TAK-935 After Oral Administration
Measured: Day 1 pre-dose and at multiple time points (up to 48 hours) post-dose in Treatment Period 1
Period 1: AUC0-inf: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for TAK-935 After Oral Administration
Measured: Day 1 pre-dose and at multiple time points (up to 48 hours) post-dose in Treatment Period 1
Period 1: AUC0-inf: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for [14C]TAK-935 After IV Administration
Measured: Day 1 pre-dose and at multiple time points (up to 47.5 hours) post-dose in Treatment Period 1
Period 1: AUC0-t: Area Under the Plasma Concentration-time Curve From Time 0 to t After Oral Administration
Measured: Day 1 pre-dose and at multiple time points (up to 48 hours) post-dose in Treatment Period 1
Period 1: AUC0-t: Area Under the Plasma Concentration-time Curve From Time 0 to Time t for TAK-935 After IV Administration
Measured: Day 1 pre-dose and at multiple time points (up to 47.5 hours) post-dose in Treatment Period 1
Period 1: AUC0-last: Area Under the Plasma Concentration-time Curve From Time 0 to Last Quantifiable Concentration for TAK-935 After Oral Administration
Measured: Day 1 pre-dose and at multiple time points (up to 48 hours) post-dose in Treatment Period 1
Period 1: AUC0-last: Area Under the Plasma Concentration-time Curve From Time 0 to Last Quantifiable Concentration for [14C]TAK-935 After IV Administration
Measured: Day 1 pre-dose and at multiple time points (up to 47.5 hours) post-dose in Treatment Period 1
Period 1: t(1/2)z: Terminal Disposition Half-life for TAK-935 After Oral Administration in Plasma
Measured: Day 1 pre-dose and at multiple time points (up to 48 hours) post-dose
Period 1: t(1/2)z: Terminal Disposition Half-life for [14C]TAK-935 After IV Administration in Plasma
Measured: Day 1 pre-dose and at multiple time points (up to 47.5 hours) post-dose
Period 1: Total Radioactivity Expressed as Amount of [14C]TAK-935 Excreted in Urine (CumAe[u]) After IV Administration
Measured: Day 1 pre-dose and at multiple time points (up to 120 hours) post-dose in Treatment Period 1
Period 1: Total Radioactivity Expressed as Amount of [14C]TAK-935 Excreted in Feces (CumAe[f]) After IV Administration
Measured: Day 1 pre-dose and at multiple time points (up to 120 hours) post-dose in Treatment Period 1
Period 1: Total Radioactivity Expressed as Amount of [14C]TAK-935 Excreted in Urine and Feces Combined (Combined CumAe) After IV Administration
Measured: Day 1 pre-dose and at multiple time points (up to 120 hours) post-dose in Treatment Period 1
Period 1: Percentage of Administered Radioactive Dose of [14C]TAK-935 Excreted in Urine (Cum%Dose[u]) After IV Administration
Measured: Day 1 pre-dose and at multiple time points (up to 120 hours) post-dose in Treatment Period 1
Period 1: Percentage of Administered Radioactive Dose of [14C]TAK-935 Excreted in Feces (%Dose[f]) After IV Administration
Measured: Day 1 pre-dose and at multiple time points (up to 120 hours) post-dose in Treatment Period 1
Period 2: Metabolic Profile of TAK-935 in Plasma After Oral Administration of [14C]TAK-935
The metabolic profile of TAK-935 after oral administration of [14C]TAK-935 was done to assess the presence of TAK-935 and various metabolites (M1 to M9) in plasma in at least one sample using radiometric detection and/or liquid chromatography mass spectroscopy (LCMS). The presence of any metabolite is indicated as '1' and absence is indicated as '0'. Only categories with value '1' are reported.
Measured: Day 1 pre-dose and at multiple time points (up to 120 hours) post-dose in Treatment Period 2
Period 2: Metabolic Profile of TAK-935 in Urine and Feces After Oral Administration of [14C]TAK-935
The metabolic profile of TAK-935 after oral administration of [14C]TAK-935 was done to assess the presence of TAK-935 and various metabolites (M1 to M9) in urine and feces in at least one sample using radiometric detection and/or LCMS. The presence of any metabolite is indicated as '1' and absence is indicated as '0'. Data is reported separately for urine and feces.
Measured: Day 1 pre-dose and at multiple time points (up to 120 hours) post-dose in Treatment Period 2
Percentage of Participants Reporting One or More Treatment Emergent Adverse Events (TEAEs)
An Adverse Event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (example, a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, whether or not it is considered related to the drug. A TEAE is defined as an AE that is starting or worsening at the time of or after study drug administration.
Measured: From first dose up to 30 days after last dose of study drug (up to approximately 40 days)
Percentage of Participants With Treatment Emergent Clinically Relevant Changes in Electrocardiogram (ECG) Parameters
Measured: From first dose up to 30 days after last dose of study drug (up to approximately 40 days)
Percentage of Participants With Treatment Emergent Clinically Relevant Changes in Vital Sign Parameters
Vital Signs included blood pressure (systolic and diastolic), heart rate (HR), respiratory rate, and temperature.
Measured: From first dose up to 30 days after last dose of study drug (up to approximately 40 days)
Percentage of Participants With Treatment Emergent Clinically Relevant Changes in Laboratory Parameters
The laboratory parameters included tests for serum chemistry, hematology, coagulation, and urinalysis.
Measured: From first dose up to 30 days after last dose of study drug (up to approximately 40 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2021
- Study start9 Jul 2020
- Primary completion18 Aug 2020
- Study completion18 Aug 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Healthy VolunteersStudies of the same condition, open and under way.
- More trials run by TakedaThe 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Takeda
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Study Director, Study director, Takeda (Note: This product was divested to Mistrau Bio, Inc. in 2026)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04992442
- Sponsor's protocol ID
- TAK-935-1008
- Status last verified
- Aug 2026
- First submitted
- 3 Aug 2021
- Last updated
- 14 Sep 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Study to Assess Absolute Bioavailability of TAK-935 (OV935) and to Characterize Mass Balance, Pharmacokinetics, Metabolism, and Excretion of [14C]TAK-935 (OV935) in Healthy Adult Male Participants
- ClinicalTrials.gov ID
- NCT04992442
- Acronym / sponsor ID
- TAK-935-1008
- Conditions
- Healthy Volunteers
- Keywords
- Drug Therapy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- TakedaIndustry (pharma, biotech, devices)
- Study start
- 9 Jul 2020 (actual)
- Primary completion
- 18 Aug 2020 (actual)
- Study completion
- 18 Aug 2020 (actual)
- First posted
- 5 Aug 2021 (actual)
- Results
- Posted 4 Oct 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine absolute bioavailability (ABA) of TAK-935 (F) following a single microdose intravenous (IV) administration of 50 microgram (μg) (approximately 1 microcurie [μCi]) [14C]TAK-935 and a single oral administration of 3×100 mg milligram (mg) TAK-935 tablets in Treatment Period 1, and to assess the mass balance, characterize the pharmacokinetics (PK) of TAK-935 and metabolite [M-I (N-oxide)] in plasma and urine, and total radioactivity concentration equivalents in plasma and whole blood following a single oral administration of 300 mg (approximately 100 μCi) [14C]TAK-935 in Treatment Period 2.
Detailed description
The drug being tested in this study is called TAK-935 (also known as soticlestat/OV935). The study determines ABA in Treatment Period 1, and the absorption, metabolism, excretion, and mass balance of TAK-935 after single oral administration in Treatment Period 2 in healthy adult male participants, by collecting plasma, urine, and feces samples for drug concentration analysis, and plasma, whole blood, urine, and fecal samples for total radioactivity analysis and metabolic profiling.
The study will enroll approximately 6 healthy adult male participants. The study is designed to consist of 2 periods: Treatment Period 1 (ABA Study Period) and Treatment Period 2 (Absorption, Distribution, Metabolism, and Elimination [ADME] Study Period). In Treatment Period 1, all participants will receive a single unlabelled oral dose of TAK-935 as 3×100 mg tablets and a microdose IV infusion of 50 μg (approximately 1 μCi) [14C]TAK-935, followed by a Washout Period of 7 days before the dose in Treatment Period 2. In Treatment Period 2, all participants will receive a single dose of 300 mg (approximately 100 μCi) [14C]TAK-935 as an oral solution.
This single center trial will be conducted in the United States. The overall time to participate in this study is approximately 65 days including Screening Period. Participants will be contacted approximately 30 days after the last dose of study drug for a follow-up assessment. This compound was transferred to Takeda and acquired on 29 March 2021. This registration is retrospective due to the transfer of ownership.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| TAK-935 300 mg + [14C]TAK-935 50 μg + [14C]TAK-935 300 mg | Experimental | Drug: TAK-935 Oral Tablet, Drug: [14C]TAK-935 IV Infusion, Drug: [14C]TAK-935 Oral SolutionTAK-935 3×100 mg, tablets, orally, once on Day 1, followed by [14C]TAK-935 50 micrograms (μg) [approximately 1 μCi], IV infusion, once on Day 1 of Treatment Period 1, followed by a Washout Period of 7 days, further followed by [14C]TAK-935 300 mg (approximately 100 μCi) solution, orally, once on Day 1 of Treatment Period 2. |
Who may qualify
- Ages
- 19 to 55 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Weighs at least 50 kg and body mass index (BMI) ≥18.0 and ˂32.0 kg/m^2 at Screening Visit.
- Continuous nonsmoker who has not used nicotine-containing products (including vaping) for at least 3 months prior to the first dosing and throughout the study, based on participant self-reporting.
- Medically healthy with no clinically significant medical history, physical examination, laboratory profiles, vital signs or ECGs, as deemed by the Investigator or designee.
Key exclusion criteria (21 listed)
- History or presence of cataracts or other clinically significant vision disturbances.
- Abnormal and clinically significant ECG abnormality at Screening visit:
- History or presence of gastritis, gastrointestinal tract, gastric bypass surgery, or hepatic disorder or other clinical condition which, in the opinion of the Investigator or designee, may affect the absorption, distribution, metabolism, or elimination of study drug.
- Has a risk of suicide according to the Investigator's clinical judgment [e.g., per Columbia-Suicide Severity Rating Scale (C-SSRS)] or has made a suicide attempt in the previous year prior to Screening Visit.
- Positive urine drug or alcohol results at screening or first check-in.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TAK-935 Oral TabletAlso: OV935, SoticlestatTAK-935 tablet | Drug | TAK-935 300 mg + [14C]TAK-935 50 μg + [14C]TAK-935 300 mg |
| [14C]TAK-935 IV InfusionAlso: OV935[14C]TAK-935 IV infusion | Drug | TAK-935 300 mg + [14C]TAK-935 50 μg + [14C]TAK-935 300 mg |
| [14C]TAK-935 Oral SolutionAlso: OV935[14C]TAK-935 oral solution | Drug | TAK-935 300 mg + [14C]TAK-935 50 μg + [14C]TAK-935 300 mg |
Primary outcome
Period 1: Percent Absolute Bioavailability (%F) for TAK-935
Time frame: Day 1 pre-dose and at multiple time points (up to 48 hours) post-dose in Treatment Period 1
Bioavailability is defined as the proportion of a drug which enters the circulation when introduced into the body and so is able to have an active effect. Percent absolute bioavailability, calculated for plasma TAK-935 as [Actual Dose (IV) x Area Under the Concentration-time Curve from Time 0 to Infinity {AUCinf} (oral)] / [Actual Dose (oral) x AUCinf (IV)] x 100.
Period 2: Total Radioactivity Expressed as Cumulative Percentage of Dose of [14C]TAK-935 Excreted in Urine and Feces Combined [Combined Cum%Dose]
Time frame: Day 1 pre-dose and at multiple time points (up to 120 hours) post-dose in Treatment Period 2
Period 2: Total Radioactivity Expressed as Amount of [14C]TAK-935 Excreted in Urine (CumAe[u])
Time frame: Day 1 pre-dose and at multiple time points (up to 120 hours) post-dose in Treatment Period 2
Period 2: Total Radioactivity Expressed as Amount of [14C]TAK-935 Excreted in Feces (CumAe[f])
Time frame: Day 1 pre-dose and at multiple time points (up to 120 hours) post-dose in Treatment Period 2
Period 2: Total Radioactivity Expressed as Amount of [14C]TAK-935 Excreted in Urine and Feces Combined (Combined CumAe)
Time frame: Day 1 pre-dose and at multiple time points (up to 120 hours) post-dose in Treatment Period 2
Period 2: Percentage of Administered Radioactive Dose of [14C]TAK-935 Excreted in Urine (Cum%Dose[u])
Time frame: Day 1 pre-dose and at multiple time points (up to 120 hours) post-dose in Treatment Period 2
Period 2: Percentage of Administered Radioactive Dose of [14C]TAK-935 Excreted in Feces (Cum%Dose[f])
Time frame: Day 1 pre-dose and at multiple time points (up to 120 hours) post-dose in Treatment Period 2
Period 2: Cmax: Maximum Observed Plasma Concentration of TAK-935
Time frame: Day 1 pre-dose and at multiple time points (up to 120 hours) post-dose in Treatment Period 2
Period 2: Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) of TAK-935
Time frame: Day 1 pre-dose and at multiple time points (up to 120 hours) post-dose in Treatment Period 2
Period 2: t(1/2)z: Terminal Disposition Phase Half-life of TAK-935 in Plasma
Time frame: Day 1 pre-dose and at multiple time points (up to 120 hours) post-dose in Treatment Period 2
Period 2: AUC0-inf: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity of TAK-935
Time frame: Day 1 pre-dose and at multiple time points (up to 120 hours) post-dose in Treatment Period 2
Period 2: AUC0-t: Area Under the Plasma Concentration-time Curve From Time 0 to Time t for TAK-935
Time frame: Day 1 pre-dose and at multiple time points (up to 120 hours) post-dose in Treatment Period 2
Period 2: AUC0-last: Area Under the Plasma Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration of TAK-935
Time frame: Day 1 pre-dose and at multiple time points (up to 120 hours) post-dose in Treatment Period 2
Period 2: Cmax: Maximum Observed Plasma Radioactivity Concentration
Time frame: Day 1 pre-dose and at multiple time points (up to 120 hours) post-dose in Treatment Period 2
Period 2: Tmax: Time to Reach the Maximum Plasma Radioactivity Concentration (Cmax)
Time frame: Day 1 pre-dose and at multiple time points (up to 120 hours) post-dose in Treatment Period 2
Period 2: t(1/2)z: Terminal Disposition Phase Half-life of Plasma Radioactivity Concentration
Time frame: Day 1 pre-dose and at multiple time points (up to 120 hours) post-dose in Treatment Period 2
Period 2: AUC0-inf: Area Under the Plasma Radioactivity Concentration-time Curve From Time 0 to Infinity
Time frame: Day 1 pre-dose and at multiple time points (up to 120 hours) post-dose in Treatment Period 2
Period 2: AUC0-t: Area Under the Plasma Radioactivity Concentration-time Curve From Time 0 to Time t
Time frame: Day 1 pre-dose and at multiple time points (up to 120 hours) post-dose in Treatment Period 2
Period 2: AUC0-last: Area Under the Plasma Radioactivity Concentration-time Curve From Time 0 to Last Quantifiable Concentration
Time frame: Day 1 pre-dose and at multiple time points (up to 120 hours) post-dose in Treatment Period 2
Period 2: Cmax: Maximum Observed Whole Blood Radioactivity Concentration
Time frame: Day 1 pre-dose and at multiple time points (up to 120 hours) post-dose in Treatment Period 2
Period 2: Tmax: Time to Reach the Maximum Whole Blood Radioactivity Concentration (Cmax)
Time frame: Day 1 pre-dose and at multiple time points (up to 120 hours) post-dose in Treatment Period 2
Period 2: t(1/2)z: Terminal Disposition Phase Half-life of Whole Blood Radioactivity Concentration
Time frame: Day 1 pre-dose and at multiple time points (up to 120 hours) post-dose in Treatment Period 2
Period 2: AUC0-inf: Area Under the Whole Blood Radioactivity Concentration-time Curve From Time 0 to Infinity
Time frame: Day 1 pre-dose and at multiple time points (up to 120 hours) post-dose in Treatment Period 2
Period 2: AUC0-t: Area Under the Whole Blood Radioactivity Concentration-time Curve From Time 0 to t
Time frame: Day 1 pre-dose and at multiple time points (up to 120 hours) post-dose in Treatment Period 2
Period 2: AUC0-last: Area Under the Whole Blood Radioactivity Concentration-time Curve From Time 0 to Last Quantifiable Concentration
Time frame: Day 1 pre-dose and at multiple time points (up to 120 hours) post-dose in Treatment Period 2
Period 2: CLR: Renal Clearance for TAK-935 in Urine
Time frame: Day 1 pre-dose and at multiple time points (up to 120 hours) post-dose in Treatment Period 2
Renal clearance (CLr) is the volume of plasma entering the kidney that is completely cleared of drug per unit of time.
Period 2: Aet1-t2: Amount of TAK-935 Excreted in the Urine in Each Collection Interval
Time frame: 0-12, 12-24, 24-48, 48-72, 72-96, 96-120 hours post-dose in Treatment Period 2
Period 2: Whole Blood to Plasma Partitioning Ratio: Change From Baseline in Percentage of [14C]TAK-935 Radioactivity in Whole Blood Relative to Plasma
Time frame: 0.17, 0.42, 0.75, 1.5, 2.5, 4.5, 8, 12, and 24 hours post-dose in Treatment Period 2
22 secondary outcomes
Period 1: Ceoi: Plasma Concentration at the End of Infusion for [14C]TAK-935
Time frame: Day 1: At the end of infusion (at 15 minutes post dose) in Treatment Period 1
Period 1: Cmax: Maximum Observed Plasma Concentration for TAK-935 After Oral Administration
Time frame: Day 1 pre-dose and at multiple time points (up to 48 hours) post-dose in Treatment Period 1
Period 1: Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for TAK-935 After Oral Administration
Time frame: Day 1 pre-dose and at multiple time points (up to 48 hours) post-dose in Treatment Period 1
Period 1: AUC0-inf: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for TAK-935 After Oral Administration
Time frame: Day 1 pre-dose and at multiple time points (up to 48 hours) post-dose in Treatment Period 1
Period 1: AUC0-inf: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for [14C]TAK-935 After IV Administration
Time frame: Day 1 pre-dose and at multiple time points (up to 47.5 hours) post-dose in Treatment Period 1
Period 1: AUC0-t: Area Under the Plasma Concentration-time Curve From Time 0 to t After Oral Administration
Time frame: Day 1 pre-dose and at multiple time points (up to 48 hours) post-dose in Treatment Period 1
Period 1: AUC0-t: Area Under the Plasma Concentration-time Curve From Time 0 to Time t for TAK-935 After IV Administration
Time frame: Day 1 pre-dose and at multiple time points (up to 47.5 hours) post-dose in Treatment Period 1
Period 1: AUC0-last: Area Under the Plasma Concentration-time Curve From Time 0 to Last Quantifiable Concentration for TAK-935 After Oral Administration
Time frame: Day 1 pre-dose and at multiple time points (up to 48 hours) post-dose in Treatment Period 1
Period 1: AUC0-last: Area Under the Plasma Concentration-time Curve From Time 0 to Last Quantifiable Concentration for [14C]TAK-935 After IV Administration
Time frame: Day 1 pre-dose and at multiple time points (up to 47.5 hours) post-dose in Treatment Period 1
Period 1: t(1/2)z: Terminal Disposition Half-life for TAK-935 After Oral Administration in Plasma
Time frame: Day 1 pre-dose and at multiple time points (up to 48 hours) post-dose
Period 1: t(1/2)z: Terminal Disposition Half-life for [14C]TAK-935 After IV Administration in Plasma
Time frame: Day 1 pre-dose and at multiple time points (up to 47.5 hours) post-dose
Period 1: Total Radioactivity Expressed as Amount of [14C]TAK-935 Excreted in Urine (CumAe[u]) After IV Administration
Time frame: Day 1 pre-dose and at multiple time points (up to 120 hours) post-dose in Treatment Period 1
Period 1: Total Radioactivity Expressed as Amount of [14C]TAK-935 Excreted in Feces (CumAe[f]) After IV Administration
Time frame: Day 1 pre-dose and at multiple time points (up to 120 hours) post-dose in Treatment Period 1
Period 1: Total Radioactivity Expressed as Amount of [14C]TAK-935 Excreted in Urine and Feces Combined (Combined CumAe) After IV Administration
Time frame: Day 1 pre-dose and at multiple time points (up to 120 hours) post-dose in Treatment Period 1
Period 1: Percentage of Administered Radioactive Dose of [14C]TAK-935 Excreted in Urine (Cum%Dose[u]) After IV Administration
Time frame: Day 1 pre-dose and at multiple time points (up to 120 hours) post-dose in Treatment Period 1
Period 1: Percentage of Administered Radioactive Dose of [14C]TAK-935 Excreted in Feces (%Dose[f]) After IV Administration
Time frame: Day 1 pre-dose and at multiple time points (up to 120 hours) post-dose in Treatment Period 1
Period 2: Metabolic Profile of TAK-935 in Plasma After Oral Administration of [14C]TAK-935
Time frame: Day 1 pre-dose and at multiple time points (up to 120 hours) post-dose in Treatment Period 2
Period 2: Metabolic Profile of TAK-935 in Urine and Feces After Oral Administration of [14C]TAK-935
Time frame: Day 1 pre-dose and at multiple time points (up to 120 hours) post-dose in Treatment Period 2
Percentage of Participants Reporting One or More Treatment Emergent Adverse Events (TEAEs)
Time frame: From first dose up to 30 days after last dose of study drug (up to approximately 40 days)
Percentage of Participants With Treatment Emergent Clinically Relevant Changes in Electrocardiogram (ECG) Parameters
Time frame: From first dose up to 30 days after last dose of study drug (up to approximately 40 days)
Percentage of Participants With Treatment Emergent Clinically Relevant Changes in Vital Sign Parameters
Time frame: From first dose up to 30 days after last dose of study drug (up to approximately 40 days)
Percentage of Participants With Treatment Emergent Clinically Relevant Changes in Laboratory Parameters
Time frame: From first dose up to 30 days after last dose of study drug (up to approximately 40 days)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Study Director study director
Takeda (Note: This product was divested to Mistrau Bio, Inc. in 2026)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing TAK-935 Oral Tablet, [14C]TAK-935 IV Infusion and [14C]TAK-935 Oral Solution in people with Healthy Volunteers, run by Takeda at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 4 Oct 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Period 1: Percent Absolute Bioavailability (%F) for TAK-935 (time frame: Day 1 pre-dose and at multiple time points (up to 48 hours) post-dose in Treatment Period 1). The study lists 28 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Sep 2026; AzTrials last refreshed its copy on 7 Nov 2026.