Trial · NCT05064449

A Study of Soticlestat With Itraconazole and Mefenamic Acid in Healthy Adults

NCT05064449, Phase 1, Completed, Takeda; results first posted 2023-10-03

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. A Study of Soticlestat With Itraconazole and Mefenamic Acid in Healthy Adults. Trials, record NCT05064449. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05064449

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: A Study of Soticlestat With Itraconazole and Mefenamic Acid in Healthy Adults
NCT number: NCT05064449
Status: Completed
Phases: Phase 1
Enrollment: 28 participants, actual
Lead sponsor: Takeda
Conditions: Healthy Volunteers
Interventions: Soticlestat, Itraconazole, Mefenamic acid
First posted: 2021-10-01
Last updated: 2026-09-10
Results first posted: 2023-10-03

Source ClinicalTrials.gov

Registered outcomes13

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame
Primary	Part 1, Cmax: Maximum Observed Plasma Concentration for Soticlestat When Administered Alone and With Itraconazole	Soticlestat alone: Period 1, Day 1 pre-dose and at multiple timepoints (up to 96 hours) post-dose; Soticlestat with itraconazole: Period 2, Day 5 pre-dose and at multiple timepoints (up to 168 hours) post-dose
Primary	Part 2, Cmax: Maximum Observed Plasma Concentration for Soticlestat When Administered Alone and With Mefenamic Acid	Soticlestat alone: Period 1, Day 1 pre-dose and at multiple timepoints (up to 96 hours) post-dose; Soticlestat with mefenamic acid: Period 2, Day 2 pre-dose and at multiple timepoints (up to 144 hours) post-dose
Primary	Part 1, AUC∞: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for Soticlestat When Administered Alone and With Itraconazole	Soticlestat alone: Period 1, Day 1 pre-dose and at multiple timepoints (up to 96 hours) post-dose; Soticlestat with itraconazole: Period 2, Day 5 pre-dose and at multiple timepoints (up to 168 hours) post-dose
Primary	Part 2, AUC∞: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for Soticlestat When Administered Alone and With Mefenamic Acid	Soticlestat alone: Period 1, Day 1 pre-dose and at multiple timepoints (up to 96 hours) post-dose; Soticlestat with mefenamic acid: Period 2, Day 2 pre-dose and at multiple timepoints (up to 144 hours) post-dose
Primary	Part 1, AUClast: Area Under the Plasma Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration for Soticlestat When Administered Alone and With Itraconazole	Soticlestat alone: Period 1, Day 1 pre-dose and at multiple timepoints (up to 96 hours) post-dose; Soticlestat with itraconazole: Period 2, Day 5 pre-dose and at multiple timepoints (up to 168 hours) post-dose
Primary	Part 2, AUClast: Area Under the Plasma Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration for Soticlestat When Administered Alone and With Mefenamic Acid	Soticlestat alone: Period 1, Day 1 pre-dose and at multiple timepoints (up to 96 hours) post-dose; Soticlestat with mefenamic acid: Period 2, Day 2 pre-dose and at multiple timepoints (up to 144 hours) post-dose
Primary	Part 1, Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for Soticlestat When Administered Alone and With Itraconazole	Soticlestat alone: Period 1, Day 1 pre-dose and at multiple timepoints (up to 96 hours) post-dose; Soticlestat with itraconazole: Period 2, Day 5 pre-dose and at multiple timepoints (up to 168 hours) post-dose
Primary	Part 2, Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for Soticlestat When Administered Alone and With Mefenamic Acid	Soticlestat alone: Period 1, Day 1 pre-dose and at multiple timepoints (up to 96 hours) post-dose; Soticlestat with mefenamic acid: Period 2, Day 2 pre-dose and at multiple timepoints (up to 144 hours) post-dose
Secondary	Parts 1 and 2: Number of Participants Reported One or More Treatment-emergent Adverse Event (TEAE)	Part 1: from Day 1 of Period 1 up to 15 days after the last dose of soticlestat in Period 2 (up to Day 20 in Period 2); Part 2: from Day 1 of Period 1 up to 15 days after the last dose of soticlestat in Period 2 (up to Day 17 in Period 2)
Secondary	Parts 1 and 2: Number of Participants With Clinically Significant Abnormal Values for Laboratory Evaluations	Part 1: Day 1 of Period 1 up to Day 12 of Period 2; Part 2: Day 1 of Period 1 up to Day 8 of Period 2

1 to 10 of 13Source ClinicalTrials.gov

See all 13 registered outcomes

Outcomes13

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Part 1, Cmax: Maximum Observed Plasma Concentration for Soticlestat When Administered Alone and With Itraconazole	Soticlestat alone: Period 1, Day 1 pre-dose and at multiple timepoints (up to 96 hours) post-dose; Soticlestat with itraconazole: Period 2, Day 5 pre-dose and at multiple timepoints (up to 168 hours) post-dose	All participants who complied sufficiently with the protocol and display an evaluable pharmacokinetic (PK) profile (example, exposure to treatment, availability of measurements and absence of major protocol violations) were included in the PK analysis set.	nanogram per milliliter (ng/mL)	GEOMETRIC_MEAN
PRIMARY	Part 2, Cmax: Maximum Observed Plasma Concentration for Soticlestat When Administered Alone and With Mefenamic Acid	Soticlestat alone: Period 1, Day 1 pre-dose and at multiple timepoints (up to 96 hours) post-dose; Soticlestat with mefenamic acid: Period 2, Day 2 pre-dose and at multiple timepoints (up to 144 hours) post-dose	All participants who complied sufficiently with the protocol and display an evaluable PK profile (example, exposure to treatment, availability of measurements and absence of major protocol violations) were included in the PK analysis set.	ng/mL	GEOMETRIC_MEAN
PRIMARY	Part 1, AUC∞: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for Soticlestat When Administered Alone and With Itraconazole	Soticlestat alone: Period 1, Day 1 pre-dose and at multiple timepoints (up to 96 hours) post-dose; Soticlestat with itraconazole: Period 2, Day 5 pre-dose and at multiple timepoints (up to 168 hours) post-dose	All participants who complied sufficiently with the protocol and display an evaluable PK profile (example, exposure to treatment, availability of measurements and absence of major protocol violations) were included in the PK analysis set. Here, overall number of participants analyzed signified those who were evaluable for this outcome measure.	nanogramhours per milliliter(nghr/mL)	GEOMETRIC_MEAN
PRIMARY	Part 2, AUC∞: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for Soticlestat When Administered Alone and With Mefenamic Acid	Soticlestat alone: Period 1, Day 1 pre-dose and at multiple timepoints (up to 96 hours) post-dose; Soticlestat with mefenamic acid: Period 2, Day 2 pre-dose and at multiple timepoints (up to 144 hours) post-dose	All participants who complied sufficiently with the protocol and display an evaluable PK profile (example, exposure to treatment, availability of measurements and absence of major protocol violations) were included in the PK analysis set. Here, overall number of participants analyzed signified those who were evaluable for this outcome measure.	ng*hr/mL	GEOMETRIC_MEAN
PRIMARY	Part 1, AUClast: Area Under the Plasma Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration for Soticlestat When Administered Alone and With Itraconazole	Soticlestat alone: Period 1, Day 1 pre-dose and at multiple timepoints (up to 96 hours) post-dose; Soticlestat with itraconazole: Period 2, Day 5 pre-dose and at multiple timepoints (up to 168 hours) post-dose	All participants who complied sufficiently with the protocol and display an evaluable PK profile (example, exposure to treatment, availability of measurements and absence of major protocol violations) were included in the PK analysis set.	ng*hr/mL	GEOMETRIC_MEAN
PRIMARY	Part 2, AUClast: Area Under the Plasma Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration for Soticlestat When Administered Alone and With Mefenamic Acid	Soticlestat alone: Period 1, Day 1 pre-dose and at multiple timepoints (up to 96 hours) post-dose; Soticlestat with mefenamic acid: Period 2, Day 2 pre-dose and at multiple timepoints (up to 144 hours) post-dose	All participants who complied sufficiently with the protocol and display an evaluable PK profile (example, exposure to treatment, availability of measurements and absence of major protocol violations) were included in the PK analysis set.	ng*hr/mL	GEOMETRIC_MEAN
PRIMARY	Part 1, Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for Soticlestat When Administered Alone and With Itraconazole	Soticlestat alone: Period 1, Day 1 pre-dose and at multiple timepoints (up to 96 hours) post-dose; Soticlestat with itraconazole: Period 2, Day 5 pre-dose and at multiple timepoints (up to 168 hours) post-dose	All participants who complied sufficiently with the protocol and display an evaluable PK profile (example, exposure to treatment, availability of measurements and absence of major protocol violations) were included in the PK analysis set.	hour	MEDIAN
PRIMARY	Part 2, Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for Soticlestat When Administered Alone and With Mefenamic Acid	Soticlestat alone: Period 1, Day 1 pre-dose and at multiple timepoints (up to 96 hours) post-dose; Soticlestat with mefenamic acid: Period 2, Day 2 pre-dose and at multiple timepoints (up to 144 hours) post-dose	All participants who complied sufficiently with the protocol and display an evaluable PK profile (example, exposure to treatment, availability of measurements and absence of major protocol violations) were included in the PK analysis set.	hour	MEDIAN
SECONDARY	Parts 1 and 2: Number of Participants Reported One or More Treatment-emergent Adverse Event (TEAE)	Part 1: from Day 1 of Period 1 up to 15 days after the last dose of soticlestat in Period 2 (up to Day 20 in Period 2); Part 2: from Day 1 of Period 1 up to 15 days after the last dose of soticlestat in Period 2 (up to Day 17 in Period 2)	All participants who received at least one dose of the study drug(s) were included in the safety analysis set.	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Parts 1 and 2: Number of Participants With Clinically Significant Abnormal Values for Laboratory Evaluations	Part 1: Day 1 of Period 1 up to Day 12 of Period 2; Part 2: Day 1 of Period 1 up to Day 8 of Period 2	All participants who received at least one dose of the study drug(s) were included in the safety analysis set.	Participants	COUNT_OF_PARTICIPANTS

1 to 10 of 13Source ClinicalTrials.gov

See all 13 outcomes

Results by group46

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Spread	Units
Part 1, Cmax: Maximum Observed Plasma Concentration for Soticlestat When Administered Alone and With Itraconazole	Part 1: Soticlestat 300 mg Alone	1310	Geometric Coefficient of Variation 80.2	nanogram per milliliter (ng/mL)
Part 1, Cmax: Maximum Observed Plasma Concentration for Soticlestat When Administered Alone and With Itraconazole	Part 1: Soticlestat 300 mg + Itraconazole 200 mg	1527	Geometric Coefficient of Variation 65.5	nanogram per milliliter (ng/mL)
Part 2, Cmax: Maximum Observed Plasma Concentration for Soticlestat When Administered Alone and With Mefenamic Acid	Part 2: Soticlestat 300 mg Alone	1414	Geometric Coefficient of Variation 58.4	ng/mL
Part 2, Cmax: Maximum Observed Plasma Concentration for Soticlestat When Administered Alone and With Mefenamic Acid	Part 2: Soticlestat 300 mg + Mefenamic Acid 500 mg and 250 mg	1517	Geometric Coefficient of Variation 55.8	ng/mL
Part 1, AUC∞: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for Soticlestat When Administered Alone and With Itraconazole	Part 1: Soticlestat 300 mg Alone	1483	Geometric Coefficient of Variation 56.1	nanogramhours per milliliter(nghr/mL)
Part 1, AUC∞: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for Soticlestat When Administered Alone and With Itraconazole	Part 1: Soticlestat 300 mg + Itraconazole 200 mg	1914	Geometric Coefficient of Variation 42.8	nanogramhours per milliliter(nghr/mL)
Part 2, AUC∞: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for Soticlestat When Administered Alone and With Mefenamic Acid	Part 2: Soticlestat 300 mg Alone	1533	Geometric Coefficient of Variation 42.2	ng*hr/mL
Part 2, AUC∞: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for Soticlestat When Administered Alone and With Mefenamic Acid	Part 2: Soticlestat 300 mg + Mefenamic Acid 500 mg and 250 mg	1594	Geometric Coefficient of Variation 45.6	ng*hr/mL
Part 1, AUClast: Area Under the Plasma Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration for Soticlestat When Administered Alone and With Itraconazole	Part 1: Soticlestat 300 mg Alone	1391	Geometric Coefficient of Variation 54.9	ng*hr/mL
Part 1, AUClast: Area Under the Plasma Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration for Soticlestat When Administered Alone and With Itraconazole	Part 1: Soticlestat 300 mg + Itraconazole 200 mg	1697	Geometric Coefficient of Variation 45.3	ng*hr/mL

1 to 10 of 46Source ClinicalTrials.gov

See all 46 results by group

Participant flow18

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Period 1 (1 Day)	STARTED	Part 1: Soticlestat 300 mg + Itraconazole 200 mg	14
Period 1 (1 Day)	STARTED	Part 2: Soticlestat 300 mg + Mefenamic Acid 500 mg and 250 mg	14
Period 1 (1 Day)	COMPLETED	Part 1: Soticlestat 300 mg + Itraconazole 200 mg	14
Period 1 (1 Day)	COMPLETED	Part 2: Soticlestat 300 mg + Mefenamic Acid 500 mg and 250 mg	14
Period 1 (1 Day)	NOT COMPLETED	Part 1: Soticlestat 300 mg + Itraconazole 200 mg	0
Period 1 (1 Day)	NOT COMPLETED	Part 2: Soticlestat 300 mg + Mefenamic Acid 500 mg and 250 mg	0
Washout Period (4 Days)	STARTED	Part 1: Soticlestat 300 mg + Itraconazole 200 mg	14
Washout Period (4 Days)	STARTED	Part 2: Soticlestat 300 mg + Mefenamic Acid 500 mg and 250 mg	14
Washout Period (4 Days)	COMPLETED	Part 1: Soticlestat 300 mg + Itraconazole 200 mg	14
Washout Period (4 Days)	COMPLETED	Part 2: Soticlestat 300 mg + Mefenamic Acid 500 mg and 250 mg	14

1 to 10 of 18Source ClinicalTrials.gov

See all 18 participant flow

Adverse events78

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk
other	Abdominal pain upper	Gastrointestinal disorders	Part 1: Soticlestat 300 mg Alone	0	14
other	Abdominal pain upper	Gastrointestinal disorders	Part 1: Itraconazole 200 mg Alone	1	14
other	Abdominal pain upper	Gastrointestinal disorders	Part 1: Soticlestat 300 mg + Itraconazole 200 mg	1	14
other	Abdominal pain upper	Gastrointestinal disorders	Part 2: Soticlestat 300 mg Alone	1	14
other	Abdominal pain upper	Gastrointestinal disorders	Part 2: Mefenamic Acid 500 mg and 250 mg	0	14
other	Abdominal pain upper	Gastrointestinal disorders	Part 2: Soticlestat 300 mg + Mefenamic Acid 500 mg and 250 mg	0	14
other	Chest discomfort	General disorders	Part 1: Soticlestat 300 mg Alone	0	14
other	Chest discomfort	General disorders	Part 1: Itraconazole 200 mg Alone	0	14
other	Chest discomfort	General disorders	Part 1: Soticlestat 300 mg + Itraconazole 200 mg	0	14
other	Chest discomfort	General disorders	Part 2: Soticlestat 300 mg Alone	0	14

1 to 10 of 78Source ClinicalTrials.gov

See all 78 adverse events

Adverse event totals18

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Part 1: Soticlestat 300 mg Alone	0	14
Total, all-cause mortality	Part 1: Itraconazole 200 mg Alone	0	14
Total, all-cause mortality	Part 1: Soticlestat 300 mg + Itraconazole 200 mg	0	14
Total, all-cause mortality	Part 2: Soticlestat 300 mg Alone	0	14
Total, all-cause mortality	Part 2: Mefenamic Acid 500 mg and 250 mg	0	14
Total, all-cause mortality	Part 2: Soticlestat 300 mg + Mefenamic Acid 500 mg and 250 mg	0	14
Total, other adverse events	Part 1: Soticlestat 300 mg Alone	1	14
Total, other adverse events	Part 1: Itraconazole 200 mg Alone	2	14
Total, other adverse events	Part 1: Soticlestat 300 mg + Itraconazole 200 mg	3	14
Total, other adverse events	Part 2: Soticlestat 300 mg Alone	1	14

1 to 10 of 18Source ClinicalTrials.gov

See all 18 adverse event totals

Papers0

The papers the trial lists on ClinicalTrials.gov.

None in this release.

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons0

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

None in this release.

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

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