Trial Outcomes & Findings for A Study of Soticlestat and Rifampin in Healthy Adults (NCT NCT05098041)
NCT ID: NCT05098041
Last Updated: 2023-11-22
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
15 participants
Primary outcome timeframe
Soticlestat Alone: Day 1 pre-dose and at multiple timepoints (up to 96 hours) post-dose in Period 1; Soticlestat with Rifampin: Day 11 pre-dose and at multiple time points (up to 72 hours) post-dose in Period 2
Results posted on
2023-11-22
Participant Flow
Participants took part in the study at 1 investigative site in United Kingdom from 22 November 2021 to 03 March 2022.
Healthy participants were enrolled in this 2-period study to receive soticlestat tablets alone in Period 1 and soticlestat tablets and rifampin capsules in Period 2 of the study.
Participant milestones
| Measure |
All Participants: Soticlestat 300 mg + Rifampin 600 mg + Soticlestat 300 mg
Soticlestat 300 milligram (mg) (3\*100 mg) immediate-release (T4) tablet, orally, once on Day 1 in fasted state in Period 1, followed by a washout period of 4 days, further followed by Rifampin 600 mg (2\*300 mg), capsules, orally, once daily from Day 1 to Day 13 along with soticlestat 300 mg (3\*100 mg) T4 tablet, orally, once on Day 11 in fasted state in Period 2.
|
|---|---|
|
Period 1 (1 Day)
STARTED
|
15
|
|
Period 1 (1 Day)
COMPLETED
|
14
|
|
Period 1 (1 Day)
NOT COMPLETED
|
1
|
|
Washout Period (4 Days)
STARTED
|
14
|
|
Washout Period (4 Days)
COMPLETED
|
14
|
|
Washout Period (4 Days)
NOT COMPLETED
|
0
|
|
Period 2 (13 Days)
STARTED
|
14
|
|
Period 2 (13 Days)
COMPLETED
|
14
|
|
Period 2 (13 Days)
NOT COMPLETED
|
0
|
Reasons for withdrawal
| Measure |
All Participants: Soticlestat 300 mg + Rifampin 600 mg + Soticlestat 300 mg
Soticlestat 300 milligram (mg) (3\*100 mg) immediate-release (T4) tablet, orally, once on Day 1 in fasted state in Period 1, followed by a washout period of 4 days, further followed by Rifampin 600 mg (2\*300 mg), capsules, orally, once daily from Day 1 to Day 13 along with soticlestat 300 mg (3\*100 mg) T4 tablet, orally, once on Day 11 in fasted state in Period 2.
|
|---|---|
|
Period 1 (1 Day)
Withdrawal by Subject
|
1
|
Baseline Characteristics
A Study of Soticlestat and Rifampin in Healthy Adults
Baseline characteristics by cohort
| Measure |
All Participants: Soticlestat 300 mg + Rifampin 600 mg + Soticlestat 300 mg
n=15 Participants
Soticlestat 300 mg (3\*100 mg) immediate-release (T4) tablet, orally, once on Day 1 in fasted state in Period 1, followed by a washout period of 4 days, further followed by Rifampin 600 mg (2\*300 mg), capsules, orally, once daily from Day 1 to Day 13 along with soticlestat 300 mg (3\*100 mg) T4 tablet, orally, once on Day 11 in fasted state in Period 2.
|
|---|---|
|
Age, Continuous
|
38.1 years
STANDARD_DEVIATION 10.07 • n=93 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=93 Participants
|
|
Sex: Female, Male
Male
|
14 Participants
n=93 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=93 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
15 Participants
n=93 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
White
|
15 Participants
n=93 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
|
Region of Enrollment
United Kingdom
|
15 Participants
n=93 Participants
|
|
Height
|
173.9 centimeter (cm)
STANDARD_DEVIATION 5.73 • n=93 Participants
|
|
Weight
|
80.72 kilogram (kg)
STANDARD_DEVIATION 10.176 • n=93 Participants
|
|
Body Mass Index (BMI)
|
26.713 kilogram per square meter (kg/m^2)
STANDARD_DEVIATION 3.1941 • n=93 Participants
|
PRIMARY outcome
Timeframe: Soticlestat Alone: Day 1 pre-dose and at multiple timepoints (up to 96 hours) post-dose in Period 1; Soticlestat with Rifampin: Day 11 pre-dose and at multiple time points (up to 72 hours) post-dose in Period 2Population: The pharmacokinetic (PK) set included 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).
Outcome measures
| Measure |
Soticlestat 300 mg Alone
n=15 Participants
Soticlestat 300 mg (3\*100 mg) T4 tablet, orally, once on Day 1 in fasted state in Period 1.
|
Soticlestat 300 mg + Rifampin 600 mg
n=14 Participants
Rifampin 600 mg (2\*300 mg), capsules, orally, once daily from Day 1 to Day 13 along with soticlestat 300 mg (3\*100 mg) T4 tablet, orally, once on Day 11 in fasted state in Period 2.
|
Soticlestat 300 mg + Rifampin 600 mg
Rifampin 600 mg (2\*300 mg), capsules, orally, once daily from Day 1 to Day 13 along with soticlestat 300 mg (3\*100 mg) T4 tablet, orally, once on Day 11 in fasted state in Period 2.
|
|---|---|---|---|
|
Cmax: Maximum Observed Plasma Concentration for Soticlestat When Administered Alone and With Rifampin
|
1364 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 63.6
|
176.8 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 99.6
|
—
|
PRIMARY outcome
Timeframe: Soticlestat Alone: Day 1 pre-dose and at multiple timepoints (up to 96 hours) post-dose in Period 1; Soticlestat with Rifampin: Day 11 pre-dose and at multiple time points (up to 72 hours) post-dose in Period 2Population: The PK set included 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). Here, "overall number of participants analyzed" signified those who were evaluable for this outcome measure.
Outcome measures
| Measure |
Soticlestat 300 mg Alone
n=13 Participants
Soticlestat 300 mg (3\*100 mg) T4 tablet, orally, once on Day 1 in fasted state in Period 1.
|
Soticlestat 300 mg + Rifampin 600 mg
n=11 Participants
Rifampin 600 mg (2\*300 mg), capsules, orally, once daily from Day 1 to Day 13 along with soticlestat 300 mg (3\*100 mg) T4 tablet, orally, once on Day 11 in fasted state in Period 2.
|
Soticlestat 300 mg + Rifampin 600 mg
Rifampin 600 mg (2\*300 mg), capsules, orally, once daily from Day 1 to Day 13 along with soticlestat 300 mg (3\*100 mg) T4 tablet, orally, once on Day 11 in fasted state in Period 2.
|
|---|---|---|---|
|
AUC∞: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for Soticlestat When Administered Alone and With Rifampin
|
1448 nanogram*hour per milliliter(ng*hr/mL)
Geometric Coefficient of Variation 47.0
|
226.2 nanogram*hour per milliliter(ng*hr/mL)
Geometric Coefficient of Variation 94.0
|
—
|
PRIMARY outcome
Timeframe: Soticlestat Alone: Day 1 pre-dose and at multiple timepoints (up to 96 hours) post-dose in Period 1; Soticlestat with Rifampin: Day 11 pre-dose and at multiple time points (up to 72 hours) post-dose in Period 2Population: The PK set included 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).
Outcome measures
| Measure |
Soticlestat 300 mg Alone
n=15 Participants
Soticlestat 300 mg (3\*100 mg) T4 tablet, orally, once on Day 1 in fasted state in Period 1.
|
Soticlestat 300 mg + Rifampin 600 mg
n=14 Participants
Rifampin 600 mg (2\*300 mg), capsules, orally, once daily from Day 1 to Day 13 along with soticlestat 300 mg (3\*100 mg) T4 tablet, orally, once on Day 11 in fasted state in Period 2.
|
Soticlestat 300 mg + Rifampin 600 mg
Rifampin 600 mg (2\*300 mg), capsules, orally, once daily from Day 1 to Day 13 along with soticlestat 300 mg (3\*100 mg) T4 tablet, orally, once on Day 11 in fasted state in Period 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 Rifampin
|
1290 ng*hr/mL
Geometric Coefficient of Variation 52.9
|
190.6 ng*hr/mL
Geometric Coefficient of Variation 88.2
|
—
|
PRIMARY outcome
Timeframe: Soticlestat Alone: Day 1 pre-dose and at multiple timepoints (up to 96 hours) post-dose in Period 1; Soticlestat with Rifampin: Day 11 pre-dose and at multiple time points (up to 72 hours) post-dose in Period 2Population: The PK set included 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).
Outcome measures
| Measure |
Soticlestat 300 mg Alone
n=15 Participants
Soticlestat 300 mg (3\*100 mg) T4 tablet, orally, once on Day 1 in fasted state in Period 1.
|
Soticlestat 300 mg + Rifampin 600 mg
n=14 Participants
Rifampin 600 mg (2\*300 mg), capsules, orally, once daily from Day 1 to Day 13 along with soticlestat 300 mg (3\*100 mg) T4 tablet, orally, once on Day 11 in fasted state in Period 2.
|
Soticlestat 300 mg + Rifampin 600 mg
Rifampin 600 mg (2\*300 mg), capsules, orally, once daily from Day 1 to Day 13 along with soticlestat 300 mg (3\*100 mg) T4 tablet, orally, once on Day 11 in fasted state in Period 2.
|
|---|---|---|---|
|
Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for Soticlestat When Administered Alone and With Rifampin
|
0.504 hour
Interval 0.24 to 0.76
|
0.499 hour
Interval 0.27 to 0.75
|
—
|
SECONDARY outcome
Timeframe: From Day 1 of Period 1 up to 15 days after the last dose of Soticlestat in Period 2 (up to Day 31)Population: The safety set included all participants who received at least one dose of the study drug(s).
Outcome measures
| Measure |
Soticlestat 300 mg Alone
n=15 Participants
Soticlestat 300 mg (3\*100 mg) T4 tablet, orally, once on Day 1 in fasted state in Period 1.
|
Soticlestat 300 mg + Rifampin 600 mg
n=14 Participants
Rifampin 600 mg (2\*300 mg), capsules, orally, once daily from Day 1 to Day 13 along with soticlestat 300 mg (3\*100 mg) T4 tablet, orally, once on Day 11 in fasted state in Period 2.
|
Soticlestat 300 mg + Rifampin 600 mg
n=14 Participants
Rifampin 600 mg (2\*300 mg), capsules, orally, once daily from Day 1 to Day 13 along with soticlestat 300 mg (3\*100 mg) T4 tablet, orally, once on Day 11 in fasted state in Period 2.
|
|---|---|---|---|
|
Number of Participants Reported One or More Treatment-Emergent Adverse Events (TEAEs)
|
2 Participants
|
1 Participants
|
2 Participants
|
Adverse Events
Soticlestat 300 mg Alone
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Rifampin 600 mg Alone
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Soticlestat 300 mg + Rifampin 600 mg
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Soticlestat 300 mg Alone
n=15 participants at risk
Soticlestat 300 mg (3\*100 mg) T4 tablet, orally, once on Day 1 in fasted state in Period 1.
|
Rifampin 600 mg Alone
n=14 participants at risk
Rifampin 600 mg (2\*300 mg), capsules, orally, once daily from Day 1 to Day 13 in fasted state in Period 2.
|
Soticlestat 300 mg + Rifampin 600 mg
n=14 participants at risk
Rifampin 600 mg (2\*300 mg), capsules, orally, once daily from Day 1 to Day 13 along with soticlestat 300 mg (3\*100 mg) T4 tablet, orally, once on Day 11 in fasted state in Period 2.
|
|---|---|---|---|
|
Infections and infestations
Bacteriuria
|
6.7%
1/15 • TEAEs were adverse events (AE) that started from Day 1 of Period 1 up to 15 days after the last dose of Soticlestat in Period 2 (up to Day 31)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/14 • TEAEs were adverse events (AE) that started from Day 1 of Period 1 up to 15 days after the last dose of Soticlestat in Period 2 (up to Day 31)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/14 • TEAEs were adverse events (AE) that started from Day 1 of Period 1 up to 15 days after the last dose of Soticlestat in Period 2 (up to Day 31)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
General disorders
Catheter site erythema
|
6.7%
1/15 • TEAEs were adverse events (AE) that started from Day 1 of Period 1 up to 15 days after the last dose of Soticlestat in Period 2 (up to Day 31)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/14 • TEAEs were adverse events (AE) that started from Day 1 of Period 1 up to 15 days after the last dose of Soticlestat in Period 2 (up to Day 31)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/14 • TEAEs were adverse events (AE) that started from Day 1 of Period 1 up to 15 days after the last dose of Soticlestat in Period 2 (up to Day 31)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/15 • TEAEs were adverse events (AE) that started from Day 1 of Period 1 up to 15 days after the last dose of Soticlestat in Period 2 (up to Day 31)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/14 • TEAEs were adverse events (AE) that started from Day 1 of Period 1 up to 15 days after the last dose of Soticlestat in Period 2 (up to Day 31)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
7.1%
1/14 • TEAEs were adverse events (AE) that started from Day 1 of Period 1 up to 15 days after the last dose of Soticlestat in Period 2 (up to Day 31)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
General disorders
Fatigue
|
0.00%
0/15 • TEAEs were adverse events (AE) that started from Day 1 of Period 1 up to 15 days after the last dose of Soticlestat in Period 2 (up to Day 31)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/14 • TEAEs were adverse events (AE) that started from Day 1 of Period 1 up to 15 days after the last dose of Soticlestat in Period 2 (up to Day 31)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
7.1%
1/14 • TEAEs were adverse events (AE) that started from Day 1 of Period 1 up to 15 days after the last dose of Soticlestat in Period 2 (up to Day 31)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Nervous system disorders
Headache
|
6.7%
1/15 • TEAEs were adverse events (AE) that started from Day 1 of Period 1 up to 15 days after the last dose of Soticlestat in Period 2 (up to Day 31)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/14 • TEAEs were adverse events (AE) that started from Day 1 of Period 1 up to 15 days after the last dose of Soticlestat in Period 2 (up to Day 31)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/14 • TEAEs were adverse events (AE) that started from Day 1 of Period 1 up to 15 days after the last dose of Soticlestat in Period 2 (up to Day 31)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Blood and lymphatic system disorders
Leukopenia
|
0.00%
0/15 • TEAEs were adverse events (AE) that started from Day 1 of Period 1 up to 15 days after the last dose of Soticlestat in Period 2 (up to Day 31)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
7.1%
1/14 • TEAEs were adverse events (AE) that started from Day 1 of Period 1 up to 15 days after the last dose of Soticlestat in Period 2 (up to Day 31)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/14 • TEAEs were adverse events (AE) that started from Day 1 of Period 1 up to 15 days after the last dose of Soticlestat in Period 2 (up to Day 31)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/15 • TEAEs were adverse events (AE) that started from Day 1 of Period 1 up to 15 days after the last dose of Soticlestat in Period 2 (up to Day 31)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/14 • TEAEs were adverse events (AE) that started from Day 1 of Period 1 up to 15 days after the last dose of Soticlestat in Period 2 (up to Day 31)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
7.1%
1/14 • TEAEs were adverse events (AE) that started from Day 1 of Period 1 up to 15 days after the last dose of Soticlestat in Period 2 (up to Day 31)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Nervous system disorders
Somnolence
|
0.00%
0/15 • TEAEs were adverse events (AE) that started from Day 1 of Period 1 up to 15 days after the last dose of Soticlestat in Period 2 (up to Day 31)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/14 • TEAEs were adverse events (AE) that started from Day 1 of Period 1 up to 15 days after the last dose of Soticlestat in Period 2 (up to Day 31)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
7.1%
1/14 • TEAEs were adverse events (AE) that started from Day 1 of Period 1 up to 15 days after the last dose of Soticlestat in Period 2 (up to Day 31)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/15 • TEAEs were adverse events (AE) that started from Day 1 of Period 1 up to 15 days after the last dose of Soticlestat in Period 2 (up to Day 31)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
7.1%
1/14 • TEAEs were adverse events (AE) that started from Day 1 of Period 1 up to 15 days after the last dose of Soticlestat in Period 2 (up to Day 31)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/14 • TEAEs were adverse events (AE) that started from Day 1 of Period 1 up to 15 days after the last dose of Soticlestat in Period 2 (up to Day 31)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Research Organization shall not publish any articles or papers nor make any presentations, nor assist any other person in publishing any articles or papers or in making any presentations relating or referring to the Study or any results, data or insights from or any data, information or materials obtained or generated in the performance of its obligations without the prior written consent of Takeda, which consent may be granted or withheld in Takeda's sole discretion.
- Publication restrictions are in place
Restriction type: OTHER