Trial Outcomes & Findings for Study of Potential CYP3A4 Induction by INDV-2000 in Healthy Adults (NCT NCT05694533)

NCT ID: NCT05694533

Last Updated: 2024-05-28

Results Overview

• Recruitment status: COMPLETED
• Study phase: PHASE1
• Target enrollment: 20 participants
• Primary outcome timeframe: Day 1 and Day 15
• Results posted on: 2024-05-28

Participant Flow

Participant milestones

Measure	INDV-2000 BID + Midazolam Participants received a single oral dose of 5 mg midazolam on Day 1. Participants received a dose of INDV-2000 twice a day (BID) from Days 2 to 15. On Day 15 participants also received a single oral dose of 5 mg midazolam co-administered with the INDV-2000 morning dose. INDV-2000: Capsules administered orally twice a day Midazolam: Midazolam syrup administered orally on Days 1 and 15
Overall Study STARTED	20
Overall Study COMPLETED	20
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Study of Potential CYP3A4 Induction by INDV-2000 in Healthy Adults

Baseline characteristics by cohort

Measure	INDV-2000 BID + Midazolam n=20 Participants Participants received a single oral dose of 5 mg midazolam on Day 1. Participants received a dose of INDV-2000 twice a day (BID) from Days 2 to 15. On Day 15 participants also received a single oral dose of 5 mg midazolam co-administered with the INDV-2000 morning dose. INDV-2000: Capsules administered orally twice a day Midazolam: Midazolam syrup administered orally on Days 1 and 15
Age, Continuous	39.0 years STANDARD_DEVIATION 8.51 • n=5 Participants
Sex: Female, Male Female	7 Participants n=5 Participants
Sex: Female, Male Male	13 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	2 Participants n=5 Participants
Race (NIH/OMB) White	15 Participants n=5 Participants
Race (NIH/OMB) More than one race	2 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	20 participants n=5 Participants

PRIMARY outcome

Timeframe: Day 1 and Day 15

Outcome measures

Measure	INDV-2000 BID + Midazolam n=20 Participants Participants received a single oral dose of 5 mg midazolam on Day 1. Participants received a dose of INDV-2000 twice a day (BID) from Days 2 to 15. On Day 15 participants also received a single oral dose of 5 mg midazolam co-administered with the INDV-2000 morning dose. INDV-2000: Capsules administered orally twice a day Midazolam: Midazolam syrup administered orally on Days 1 and 15	INDV-2000 INDV-2000 alone	Midazolam + INDV-2000 INDV-2000 co-administered with midazolam
Maximum Observed Plasma Concentration (Cmax) of Midazolam and 1-hydroxymidazolam Midazolam Day 1	22.0 ng/mL Geometric Coefficient of Variation 47.2	—	—
Maximum Observed Plasma Concentration (Cmax) of Midazolam and 1-hydroxymidazolam Midazolam Day 15	18.5 ng/mL Geometric Coefficient of Variation 30.8	—	—
Maximum Observed Plasma Concentration (Cmax) of Midazolam and 1-hydroxymidazolam 1-Hydroxymidazolam Day 1	9.92 ng/mL Geometric Coefficient of Variation 47.1	—	—
Maximum Observed Plasma Concentration (Cmax) of Midazolam and 1-hydroxymidazolam 1-Hydroxymidazolam Day 15	7.97 ng/mL Geometric Coefficient of Variation 40.9	—	—

PRIMARY outcome

Timeframe: Day 1 and Day 15

Outcome measures

Measure	INDV-2000 BID + Midazolam n=20 Participants Participants received a single oral dose of 5 mg midazolam on Day 1. Participants received a dose of INDV-2000 twice a day (BID) from Days 2 to 15. On Day 15 participants also received a single oral dose of 5 mg midazolam co-administered with the INDV-2000 morning dose. INDV-2000: Capsules administered orally twice a day Midazolam: Midazolam syrup administered orally on Days 1 and 15	INDV-2000 INDV-2000 alone	Midazolam + INDV-2000 INDV-2000 co-administered with midazolam
Area Under the Plasma Concentration-time Curve From Time Zero Extrapolated to Infinity (AUC0-∞) of Midazolam and 1-hydroxymidazolam Midazolam Day 1	57.2 hour*ng/mL Geometric Coefficient of Variation 46.1	—	—
Area Under the Plasma Concentration-time Curve From Time Zero Extrapolated to Infinity (AUC0-∞) of Midazolam and 1-hydroxymidazolam Midazolam Day 15	48.5 hour*ng/mL Geometric Coefficient of Variation 36.3	—	—
Area Under the Plasma Concentration-time Curve From Time Zero Extrapolated to Infinity (AUC0-∞) of Midazolam and 1-hydroxymidazolam 1-Hydroxymidazolam Day 1	25.2 hour*ng/mL Geometric Coefficient of Variation 35.2	—	—
Area Under the Plasma Concentration-time Curve From Time Zero Extrapolated to Infinity (AUC0-∞) of Midazolam and 1-hydroxymidazolam 1-Hydroxymidazolam Day 15	20.3 hour*ng/mL Geometric Coefficient of Variation 32.6	—	—

PRIMARY outcome

Timeframe: Day 1 and Day 15

Outcome measures

Measure	INDV-2000 BID + Midazolam n=20 Participants Participants received a single oral dose of 5 mg midazolam on Day 1. Participants received a dose of INDV-2000 twice a day (BID) from Days 2 to 15. On Day 15 participants also received a single oral dose of 5 mg midazolam co-administered with the INDV-2000 morning dose. INDV-2000: Capsules administered orally twice a day Midazolam: Midazolam syrup administered orally on Days 1 and 15	INDV-2000 INDV-2000 alone	Midazolam + INDV-2000 INDV-2000 co-administered with midazolam
Area Under the Plasma Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUClast) of Midazolam and 1-hydroxymidazolam Midazolam Day 1	55.5 hour*ng/mL Geometric Coefficient of Variation 45.5	—	—
Area Under the Plasma Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUClast) of Midazolam and 1-hydroxymidazolam Midazolam Day 15	46.9 hour*ng/mL Geometric Coefficient of Variation 35.6	—	—
Area Under the Plasma Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUClast) of Midazolam and 1-hydroxymidazolam 1-Hydroxymidazolam Day 1	23.2 hour*ng/mL Geometric Coefficient of Variation 43.4	—	—
Area Under the Plasma Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUClast) of Midazolam and 1-hydroxymidazolam 1-Hydroxymidazolam Day 15	20.1 hour*ng/mL Geometric Coefficient of Variation 33.0	—	—

SECONDARY outcome

Timeframe: From first dose of study drug to Day 22

TEAEs will be defined as adverse events that start on or after the first dose of study drug.

Outcome measures

Measure	INDV-2000 BID + Midazolam n=20 Participants Participants received a single oral dose of 5 mg midazolam on Day 1. Participants received a dose of INDV-2000 twice a day (BID) from Days 2 to 15. On Day 15 participants also received a single oral dose of 5 mg midazolam co-administered with the INDV-2000 morning dose. INDV-2000: Capsules administered orally twice a day Midazolam: Midazolam syrup administered orally on Days 1 and 15	INDV-2000 n=20 Participants INDV-2000 alone	Midazolam + INDV-2000 n=20 Participants INDV-2000 co-administered with midazolam
Number of Participants With Treatment-emergent Adverse Events (TEAEs)	7 Participants	12 Participants	3 Participants

Adverse Events

Midazolam

Serious events: 0 serious events

Other events: 7 other events

Deaths: 0 deaths

INDV-2000

Serious events: 0 serious events

Other events: 12 other events

Deaths: 0 deaths

Midazolam + INDV-2000

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Midazolam n=20 participants at risk Midazolam alone	INDV-2000 n=20 participants at risk INDV-2000 alone	Midazolam + INDV-2000 n=20 participants at risk INDV-2000 co-administered with midazolam
Nervous system disorders SOMNOLENCE	20.0% 4/20 • 22 days All AEs and SAEs were collected from informed consent form signature until the end of study (EOS) Visit on Day 22 (±2 days) or at early termination. Any ongoing AEs at the time of the EOS Visit (ie, Day 22 \[±2 days\]) or at early termination were appropriately followed-up until resolution or 14 days after the EOS Visit or early termination.	20.0% 4/20 • 22 days All AEs and SAEs were collected from informed consent form signature until the end of study (EOS) Visit on Day 22 (±2 days) or at early termination. Any ongoing AEs at the time of the EOS Visit (ie, Day 22 \[±2 days\]) or at early termination were appropriately followed-up until resolution or 14 days after the EOS Visit or early termination.	5.0% 1/20 • 22 days All AEs and SAEs were collected from informed consent form signature until the end of study (EOS) Visit on Day 22 (±2 days) or at early termination. Any ongoing AEs at the time of the EOS Visit (ie, Day 22 \[±2 days\]) or at early termination were appropriately followed-up until resolution or 14 days after the EOS Visit or early termination.
Nervous system disorders HEADACHE	5.0% 1/20 • 22 days All AEs and SAEs were collected from informed consent form signature until the end of study (EOS) Visit on Day 22 (±2 days) or at early termination. Any ongoing AEs at the time of the EOS Visit (ie, Day 22 \[±2 days\]) or at early termination were appropriately followed-up until resolution or 14 days after the EOS Visit or early termination.	20.0% 4/20 • 22 days All AEs and SAEs were collected from informed consent form signature until the end of study (EOS) Visit on Day 22 (±2 days) or at early termination. Any ongoing AEs at the time of the EOS Visit (ie, Day 22 \[±2 days\]) or at early termination were appropriately followed-up until resolution or 14 days after the EOS Visit or early termination.	10.0% 2/20 • 22 days All AEs and SAEs were collected from informed consent form signature until the end of study (EOS) Visit on Day 22 (±2 days) or at early termination. Any ongoing AEs at the time of the EOS Visit (ie, Day 22 \[±2 days\]) or at early termination were appropriately followed-up until resolution or 14 days after the EOS Visit or early termination.
Nervous system disorders DIZZINESS	10.0% 2/20 • 22 days All AEs and SAEs were collected from informed consent form signature until the end of study (EOS) Visit on Day 22 (±2 days) or at early termination. Any ongoing AEs at the time of the EOS Visit (ie, Day 22 \[±2 days\]) or at early termination were appropriately followed-up until resolution or 14 days after the EOS Visit or early termination.	5.0% 1/20 • 22 days All AEs and SAEs were collected from informed consent form signature until the end of study (EOS) Visit on Day 22 (±2 days) or at early termination. Any ongoing AEs at the time of the EOS Visit (ie, Day 22 \[±2 days\]) or at early termination were appropriately followed-up until resolution or 14 days after the EOS Visit or early termination.	0.00% 0/20 • 22 days All AEs and SAEs were collected from informed consent form signature until the end of study (EOS) Visit on Day 22 (±2 days) or at early termination. Any ongoing AEs at the time of the EOS Visit (ie, Day 22 \[±2 days\]) or at early termination were appropriately followed-up until resolution or 14 days after the EOS Visit or early termination.
Gastrointestinal disorders DRY MOUTH	0.00% 0/20 • 22 days All AEs and SAEs were collected from informed consent form signature until the end of study (EOS) Visit on Day 22 (±2 days) or at early termination. Any ongoing AEs at the time of the EOS Visit (ie, Day 22 \[±2 days\]) or at early termination were appropriately followed-up until resolution or 14 days after the EOS Visit or early termination.	15.0% 3/20 • 22 days All AEs and SAEs were collected from informed consent form signature until the end of study (EOS) Visit on Day 22 (±2 days) or at early termination. Any ongoing AEs at the time of the EOS Visit (ie, Day 22 \[±2 days\]) or at early termination were appropriately followed-up until resolution or 14 days after the EOS Visit or early termination.	0.00% 0/20 • 22 days All AEs and SAEs were collected from informed consent form signature until the end of study (EOS) Visit on Day 22 (±2 days) or at early termination. Any ongoing AEs at the time of the EOS Visit (ie, Day 22 \[±2 days\]) or at early termination were appropriately followed-up until resolution or 14 days after the EOS Visit or early termination.
Skin and subcutaneous tissue disorders DRY SKIN	0.00% 0/20 • 22 days All AEs and SAEs were collected from informed consent form signature until the end of study (EOS) Visit on Day 22 (±2 days) or at early termination. Any ongoing AEs at the time of the EOS Visit (ie, Day 22 \[±2 days\]) or at early termination were appropriately followed-up until resolution or 14 days after the EOS Visit or early termination.	15.0% 3/20 • 22 days All AEs and SAEs were collected from informed consent form signature until the end of study (EOS) Visit on Day 22 (±2 days) or at early termination. Any ongoing AEs at the time of the EOS Visit (ie, Day 22 \[±2 days\]) or at early termination were appropriately followed-up until resolution or 14 days after the EOS Visit or early termination.	0.00% 0/20 • 22 days All AEs and SAEs were collected from informed consent form signature until the end of study (EOS) Visit on Day 22 (±2 days) or at early termination. Any ongoing AEs at the time of the EOS Visit (ie, Day 22 \[±2 days\]) or at early termination were appropriately followed-up until resolution or 14 days after the EOS Visit or early termination.
General disorders FATIGUE	10.0% 2/20 • 22 days All AEs and SAEs were collected from informed consent form signature until the end of study (EOS) Visit on Day 22 (±2 days) or at early termination. Any ongoing AEs at the time of the EOS Visit (ie, Day 22 \[±2 days\]) or at early termination were appropriately followed-up until resolution or 14 days after the EOS Visit or early termination.	5.0% 1/20 • 22 days All AEs and SAEs were collected from informed consent form signature until the end of study (EOS) Visit on Day 22 (±2 days) or at early termination. Any ongoing AEs at the time of the EOS Visit (ie, Day 22 \[±2 days\]) or at early termination were appropriately followed-up until resolution or 14 days after the EOS Visit or early termination.	0.00% 0/20 • 22 days All AEs and SAEs were collected from informed consent form signature until the end of study (EOS) Visit on Day 22 (±2 days) or at early termination. Any ongoing AEs at the time of the EOS Visit (ie, Day 22 \[±2 days\]) or at early termination were appropriately followed-up until resolution or 14 days after the EOS Visit or early termination.
Gastrointestinal disorders NAUSEA	0.00% 0/20 • 22 days All AEs and SAEs were collected from informed consent form signature until the end of study (EOS) Visit on Day 22 (±2 days) or at early termination. Any ongoing AEs at the time of the EOS Visit (ie, Day 22 \[±2 days\]) or at early termination were appropriately followed-up until resolution or 14 days after the EOS Visit or early termination.	10.0% 2/20 • 22 days All AEs and SAEs were collected from informed consent form signature until the end of study (EOS) Visit on Day 22 (±2 days) or at early termination. Any ongoing AEs at the time of the EOS Visit (ie, Day 22 \[±2 days\]) or at early termination were appropriately followed-up until resolution or 14 days after the EOS Visit or early termination.	0.00% 0/20 • 22 days All AEs and SAEs were collected from informed consent form signature until the end of study (EOS) Visit on Day 22 (±2 days) or at early termination. Any ongoing AEs at the time of the EOS Visit (ie, Day 22 \[±2 days\]) or at early termination were appropriately followed-up until resolution or 14 days after the EOS Visit or early termination.
Musculoskeletal and connective tissue disorders PAIN IN EXTREMITY	0.00% 0/20 • 22 days All AEs and SAEs were collected from informed consent form signature until the end of study (EOS) Visit on Day 22 (±2 days) or at early termination. Any ongoing AEs at the time of the EOS Visit (ie, Day 22 \[±2 days\]) or at early termination were appropriately followed-up until resolution or 14 days after the EOS Visit or early termination.	10.0% 2/20 • 22 days All AEs and SAEs were collected from informed consent form signature until the end of study (EOS) Visit on Day 22 (±2 days) or at early termination. Any ongoing AEs at the time of the EOS Visit (ie, Day 22 \[±2 days\]) or at early termination were appropriately followed-up until resolution or 14 days after the EOS Visit or early termination.	0.00% 0/20 • 22 days All AEs and SAEs were collected from informed consent form signature until the end of study (EOS) Visit on Day 22 (±2 days) or at early termination. Any ongoing AEs at the time of the EOS Visit (ie, Day 22 \[±2 days\]) or at early termination were appropriately followed-up until resolution or 14 days after the EOS Visit or early termination.

Additional Information

Global Director Clinical Development

Indivior Inc.

Phone: (804) 594-4488

Email: trialdisclosure@indivior.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place

Restriction type: OTHER