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

NCT05064449 | Completed Phase 1 Results FDA Drug

• 1 other identifier: TAK-935-1007
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

Brief Summary

The main aim of this study is to check how itraconazole and mefenamic acid affect the way soticlestat is processed by the body. The study will have 2 parts. Participants can only participate in one study part. Part 1: Participants will check into the study clinic to receive soticlestat, four days later they will begin receiving itraconazole and will stay in the clinic for 11 more days, receiving soticlestat in combination with itraconazole on one of those days. Participants will be contacted about 8 days after leaving the clinic for follow-up. Part 2: Participants will check into the study clinic to receive soticlestat, four days later they will begin receiving mefenamic acid and will stay in the clinic for 7 more days, receiving soticlestat in combination with mefenamic acid on one of those days.. Participants will be contacted about 9 days after leaving the clinic for follow-up.

Conditions

Healthy Volunteers

Keywords

Drug Therapy

Outcome Measures

Primary Outcomes (8)

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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 Outcomes (5)

• 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)

• 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

• Parts 1 and 2: Number of Participants With Clinically Significant Abnormal Values for Vital Signs

  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

• Parts 1 and 2: Number of Participants With Clinically Significant Abnormal Values for Electrocardiogram (ECG)

  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

• Parts 1 and 2: Number of Participants With Suicidal Ideation or Suicidal Behavior as Measured Using Columbia-Suicide Severity Rating Scale (C-SSRS)

  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

Study Arms (2)

Part 1: Soticlestat 300 mg + Itraconazole 200 mg

EXPERIMENTAL

Soticlestat 300 milligram (mg), tablets, orally, once on Day 1 in Period 1, followed by 4 days washout period, followed by itraconazole 200 mg solution, orally, once daily from Day 1 up to Day 11, further followed by soticlestat 300 mg tablet, orally along with itraconazole 200 mg solution, orally on the morning of Day in Period 2.

Drug: Soticlestat; Drug: Itraconazole

Part 2: Soticlestat 300 mg + Mefenamic Acid 500 mg

EXPERIMENTAL

Soticlestat 300 mg, tablets, orally, once on Day 1 in Period 1, followed by 4 days washout period, followed by single dose of mefenamic acid 500 mg capsule (first dose only), orally on the morning of Day 1 and 250 mg subsequent doses at every six hours up to Day 7 in Period 2, further followed by soticlestat 300 mg tablet, orally, followed by mefenamic acid 250 mg capsule, orally in morning of Day 2 in Period 2.

Drug: Soticlestat; Drug: Mefenamic acid

Interventions

Soticlestat DRUG

Soticlestat tablets.

Also known as: TAK-935

Part 1: Soticlestat 300 mg + Itraconazole 200 mg; Part 2: Soticlestat 300 mg + Mefenamic Acid 500 mg

Itraconazole DRUG

Itraconazole oral solution.

Part 1: Soticlestat 300 mg + Itraconazole 200 mg

Mefenamic acid DRUG

Mefenamic acid capsule.

Part 2: Soticlestat 300 mg + Mefenamic Acid 500 mg

Eligibility Criteria

• Age: 19 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Has body mass index (BMI) greater than or equal to (\>=) 18.0 and less than or equal to (\<=) 32.0 kilogram per meter square (kg/m\^2) at screening.
• Continuous non-smoker who has not used nicotine-containing products for at least 90 days prior to the first dosing.
• Medically healthy with no clinically significant medical history, physical examination, laboratory profiles, vital signs or electrocardiograms (ECGs), as deemed by the Investigator or designee.
• Supine blood pressure is \>=90/40 millimeter of mercury (mmHg) and \<=140/90 mmHg at screening;
• Supine pulse rate is \>=45 beats per minute (bpm) and \<=100 bpm at screening;
• QT interval corrected for pulse rate using Fridericia's formula (QTcF) is \<=450 millisecond (msec) (males) or \<=470 msec (females) and ECG findings considered normal or not clinically significant by the Investigator or designee at screening;
• Estimated creatinine clearance \>=80 milliliter per minute (mL/min) at screening;
• Liver function tests including alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \<=1.5\*the upper limit of normal (ULN) at screening and check-in.
• Able to swallow multiple tablets.

You may not qualify if:

• Has history of any illness that, in the opinion of the Investigator or designee, might confound the results of the study or poses an additional risk to the participants by their participation in the study.
• Has history or presence of alcoholism or drug abuse within the past 2 years prior to the first dosing.
• Has history or presence of hypersensitivity or idiosyncratic reaction to the study drugs or related compounds.
• Unable to refrain from or anticipates the use of:
• Any drug, including prescription and non-prescription medications, herbal remedies, or vitamin supplements within 14 days prior to the first dosing. 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 dosing.
• Has history of alcohol consumption exceeding 2 standard drinks per day on average (1 glass is approximately equivalent to the following: beer 354 milliliter (mL)/12 Ounce \[oz\], wine \[118 mL/4 oz\], or distilled spirits \[29.5 mL/1 oz\] per day).
• Consumes excessive amounts, defined as greater than 4 servings (1 serving is approximately equivalent to 120 mg of caffeine), of coffee, tea, cola, energy drinks, or other caffeinated beverages per day.
• 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.
• Has participation in another clinical study within 30 days or 5 half-lives prior to the first dosing. The 30-day window or 5 half-lives will be derived from the date of the last blood collection or dosing, whichever is later, in the previous study to Day 1 of Period 1 of the current study.

Sponsors & Collaborators

• Takeda: lead

Study Sites (1)

Celerion

Lincoln, Nebraska, 68502, United States

Location

Related Links

• To obtain more information on the study, click here/on this link

MeSH Terms

Interventions

soticlestat; Itraconazole; Mefenamic Acid

Intervention Hierarchy (Ancestors)

Triazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Piperazines; Fenamates; ortho-Aminobenzoates; Aminobenzoates; Benzoates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons

Results Point of Contact

• Title: Study Director
• Organization: Takeda

TrialDisclosures@takeda.com

+1-877-825-3327

Study Officials

• Study Director

  Takeda

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 22, 2021
• First Posted: October 1, 2021
• Study Start: October 14, 2021
• Primary Completion: November 21, 2021
• Study Completion: November 30, 2021
• Last Updated: October 3, 2023
• Results First Posted: October 3, 2023

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Access Criteria: IPD from eligible studies will be shared with qualified researchers according to the criteria and process described on https://vivli.org/ourmember/takeda/ For approved requests, the researchers will be provided access to anonymized data (to respect patient privacy in line with applicable laws and regulations) and with information necessary to address the research objectives under the terms of a data sharing agreement.

Locations

US (1)