Trial Outcomes & Findings for Potential Influence of Esomeprazole on the Pharmacokinetics of Pritelivir (NCT NCT05513625)

NCT ID: NCT05513625

Last Updated: 2024-02-22

Results Overview

Cmax - the maximum observed plasma concentration

• Recruitment status: COMPLETED
• Study phase: PHASE1
• Target enrollment: 16 participants
• Primary outcome timeframe: 15 days
• Results posted on: 2024-02-22

Participant Flow

16 subjects enrolled in PTV 100 mg (T1), 15 completed. The 15 completed were enrolled into ESO 40 mg/PTV 100 mg (T2)

Participant milestones

Measure	100 mg Pritelivir / 40 mg qd ESO and 100 mg Pritelivir Single dose 100 mg pritelivir (PTV) administered day 1 Pritelivir: oral administration 40 mg qd ESO Day -3 to Day1. Single dose of 100 mg PTV on Day 1 ESO and pritelivir: oral administration
Overall Study STARTED	16
Overall Study COMPLETED	15
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Measure	100 mg Pritelivir / 40 mg qd ESO and 100 mg Pritelivir Single dose 100 mg pritelivir (PTV) administered day 1 Pritelivir: oral administration 40 mg qd ESO Day -3 to Day1. Single dose of 100 mg PTV on Day 1 ESO and pritelivir: oral administration
Overall Study Withdrawal by Subject	1

Baseline Characteristics

Potential Influence of Esomeprazole on the Pharmacokinetics of Pritelivir

Baseline characteristics by cohort

Measure	100 mg Pritelivir / 40 mg qd ESO and 100 mg Pritelivir n=16 Participants Single dose 100 mg pritelivir (PTV) administered day 1 Pritelivir: oral administration 40 mg qd ESO Day -3 to Day1. Single dose of 100 mg PTV on Day 1 ESO and pritelivir: oral administration
Age, Continuous	29.6 Years STANDARD_DEVIATION 8.20 • n=93 Participants
Sex: Female, Male Female	5 Participants n=93 Participants
Sex: Female, Male Male	11 Participants n=93 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 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	12 Participants n=93 Participants
Race (NIH/OMB) White	4 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

PRIMARY outcome

Timeframe: 15 days

Cmax - the maximum observed plasma concentration

Outcome measures

Measure	100 mg Pritelivir n=16 Participants Single dose 100 mg pritelivir (PTV) administered on Day 1 Pritelivir: oral administration	40 mg qd ESO and 100 mg Pritelivir n=15 Participants 40 mg qd ESO Day -3 to Day1. Single dose of 100 mg PTV on Day 1 ESO and pritelivir: oral administration
PK - Cmax	1102 ng/mL Standard Deviation 421	282 ng/mL Standard Deviation 141

PRIMARY outcome

Timeframe: 15 days

AUC0-∞ - area under the analyte vs time concentration curve from time of administration up to infinity, calculated as AUC0-∞ = AUC0-last + (Clast / λz)

AUC0-last - area under the analyte vs. time concentration curve from time of administration up to the time of the last quantifiable concentration, calculated by linear up/ln down summation

Outcome measures

Measure	100 mg Pritelivir n=15 Participants Single dose 100 mg pritelivir (PTV) administered on Day 1 Pritelivir: oral administration	40 mg qd ESO and 100 mg Pritelivir n=15 Participants 40 mg qd ESO Day -3 to Day1. Single dose of 100 mg PTV on Day 1 ESO and pritelivir: oral administration
PK - AUC(0-infinity) and AUC(0-last) AUC(0-last)	67599 ng*h/mL Standard Deviation 22012	28325 ng*h/mL Standard Deviation 11071
PK - AUC(0-infinity) and AUC(0-last) PK - AUC(0-infinity)	69140 ng*h/mL Standard Deviation 22147	29404 ng*h/mL Standard Deviation 11447

SECONDARY outcome

Timeframe: 15 days

tmax - time to reach the maximal observed analyte concentration and tlag - time period between the time of dosing and the time of the first measurable concentration

Outcome measures

Measure	100 mg Pritelivir n=16 Participants Single dose 100 mg pritelivir (PTV) administered on Day 1 Pritelivir: oral administration	40 mg qd ESO and 100 mg Pritelivir n=15 Participants 40 mg qd ESO Day -3 to Day1. Single dose of 100 mg PTV on Day 1 ESO and pritelivir: oral administration
PK - Tmax and Tlag tmax	3.00 hours Interval 0.5 to 10.0	8.00 hours Interval 0.75 to 48.0
PK - Tmax and Tlag tlag	0.00 hours Interval 0.0 to 0.25	0.00 hours Interval 0.0 to 0.25

SECONDARY outcome

Timeframe: 15 days

λz - the apparent terminal elimination rate constant, determined by linear regression of terminal points of the ln-linear analyte concentration-time curve

Outcome measures

Measure	100 mg Pritelivir n=15 Participants Single dose 100 mg pritelivir (PTV) administered on Day 1 Pritelivir: oral administration	40 mg qd ESO and 100 mg Pritelivir n=15 Participants 40 mg qd ESO Day -3 to Day1. Single dose of 100 mg PTV on Day 1 ESO and pritelivir: oral administration
PK - λz	0.0106 1/h Standard Deviation 0.0020	0.00970 1/h Standard Deviation 0.0018

SECONDARY outcome

Timeframe: 15 days

t1/2z - the apparent terminal elimination half-life calculated as: t1/2z = 0.693 / λz

Outcome measures

Measure	100 mg Pritelivir n=15 Participants Single dose 100 mg pritelivir (PTV) administered on Day 1 Pritelivir: oral administration	40 mg qd ESO and 100 mg Pritelivir n=15 Participants 40 mg qd ESO Day -3 to Day1. Single dose of 100 mg PTV on Day 1 ESO and pritelivir: oral administration
PK t1/2z	67.7 hours Standard Deviation 12	73.7 hours Standard Deviation 13

SECONDARY outcome

Timeframe: 15 days

CL/F - total apparent clearance of drug following single dose e.v. administration calculated as: CL/F = Dose / AUC0-∞

Outcome measures

Measure	100 mg Pritelivir n=15 Participants Single dose 100 mg pritelivir (PTV) administered on Day 1 Pritelivir: oral administration	40 mg qd ESO and 100 mg Pritelivir n=15 Participants 40 mg qd ESO Day -3 to Day1. Single dose of 100 mg PTV on Day 1 ESO and pritelivir: oral administration
PK - CL/F	1.58 L/h Standard Deviation 0.46	3.93 L/h Standard Deviation 1.6

SECONDARY outcome

Timeframe: 15 days

V d/F - apparent volume of distribution after a single dose e.v. administration calculated as Vd/F = Dose e.v. / (λz * AUC0-∞)

Outcome measures

Measure	100 mg Pritelivir n=15 Participants Single dose 100 mg pritelivir (PTV) administered on Day 1 Pritelivir: oral administration	40 mg qd ESO and 100 mg Pritelivir n=15 Participants 40 mg qd ESO Day -3 to Day1. Single dose of 100 mg PTV on Day 1 ESO and pritelivir: oral administration
V d/F	157 L Standard Deviation 63	432 L Standard Deviation 231

Adverse Events

100 mg Pritelivir

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

40 mg qd ESO and 100 mg Pritelivir

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	100 mg Pritelivir n=16 participants at risk Single dose 100 mg pritelivir (PTV) administered day 1 Pritelivir: oral administration	40 mg qd ESO and 100 mg Pritelivir n=15 participants at risk 40 mg qd ESO Day -3 to Day1. Single dose of 100 mg PTV on Day 1 ESO and pritelivir: oral administration
Injury, poisoning and procedural complications Ankle fracture	6.2% 1/16 • 32 days	0.00% 0/15 • 32 days
Injury, poisoning and procedural complications Lumbar vertebral fracture	0.00% 0/16 • 32 days	6.7% 1/15 • 32 days
Injury, poisoning and procedural complications Pulmonary contusion	0.00% 0/16 • 32 days	6.7% 1/15 • 32 days
Injury, poisoning and procedural complications Skin abrasion	6.2% 1/16 • 32 days	0.00% 0/15 • 32 days
Gastrointestinal disorders Tooth impacted	6.2% 1/16 • 32 days	0.00% 0/15 • 32 days
Infections and infestations Upper respiratory tract infection	0.00% 0/16 • 32 days	6.7% 1/15 • 32 days
Musculoskeletal and connective tissue disorders Myalgia	0.00% 0/16 • 32 days	6.7% 1/15 • 32 days
Nervous system disorders Headache	0.00% 0/16 • 32 days	6.7% 1/15 • 32 days

Additional Information

Information Desk

AiCuris Anti-infective Cures AG

Phone: +4920231763

Email: info@aicuris.com

Results disclosure agreements

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