Trial Outcomes & Findings for Pharmacokinetics of Plasma Doravirine Once Daily Over 72 Hours Following Drug Intake Cessation in Healthy Volunteers (NCT NCT03894124)

Results Overview

Following cessation of daily doravirine, plasma concentrations of drug to be taken before last dose and at 11 further timepoints over 72 hours. Blood samples were collected pre-dose and at 2, 4, 8, 12, 24, 30, 36, 48, 60 and 72 h post-dose

Recruitment status

COMPLETED

Study phase

PHASE1

Target enrollment

24 participants

Primary outcome timeframe

72 hours from treatment cessation; days 7-10 inclusive from enrolment

Results posted on

2024-09-19

Participant Flow

Participant milestones

Participant milestones
Measure	Study Intervention Pifeltro® (doravirine 100mg) daily dose for 7 days Doravirine: Non-nucleoside reverse transcriptase inhibitor. Administered as film coated tablet.
Overall Study STARTED	14
Overall Study COMPLETED	14
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Pharmacokinetics of Plasma Doravirine Once Daily Over 72 Hours Following Drug Intake Cessation in Healthy Volunteers

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Study Intervention n=14 Participants Pifeltro® (doravirine 100mg) daily dose for 7 days Doravirine: Non-nucleoside reverse transcriptase inhibitor. Administered as film coated tablet.
Age, Continuous	33 years n=5 Participants
Sex: Female, Male Female	7 Participants n=5 Participants
Sex: Female, Male Male	7 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	13 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United Kingdom	14 Participants n=5 Participants
Median BMI	23.3 kg/m2 n=5 Participants

PRIMARY outcome

Timeframe: 72 hours from treatment cessation; days 7-10 inclusive from enrolment

Population: Plasma concentrations of doravirine after drug intake cessation up to 72 hours post-dose were investigated in population of participants for the study

Following cessation of daily doravirine, plasma concentrations of drug to be taken before last dose and at 11 further timepoints over 72 hours. Blood samples were collected pre-dose and at 2, 4, 8, 12, 24, 30, 36, 48, 60 and 72 h post-dose

Outcome measures

Outcome measures
Measure	Study Intervention n=14 Participants Pifeltro® (doravirine 100mg) daily dose for 7 days Doravirine: Non-nucleoside reverse transcriptase inhibitor. Administered as film coated tablet.
Steady State Plasma Concentrations of Doravirine After Drug Intake Cessation up to 72 Hours Post-dose. Doravirine steady-state PK parameters measured over 24h AUC 0-24h	18354 ng*hr/mL Interval 16395.0 to 21410.0
Steady State Plasma Concentrations of Doravirine After Drug Intake Cessation up to 72 Hours Post-dose. Doravirine steady-state PK parameters measured over 24h AUC 0-72h	26338 ng*hr/mL Interval 23080.0 to 31743.0

PRIMARY outcome

Timeframe: 72 hours from treatment cessation; days 7-10 inclusive from enrolment

Population: Plasma concentrations of doravirine after drug intake cessation up to 72 hours post-dose were investigated in population of participants for the study

Following cessation of daily dorovirine, plasma concentrations of drug to be taken before last dose and at 11 further timepoints over 72 hours. Blood samples were collected at pre-dose and at 2,4,8,12,24,30,36,47,60 and 72h post-dose

Outcome measures

Outcome measures
Measure	Study Intervention n=14 Participants Pifeltro® (doravirine 100mg) daily dose for 7 days Doravirine: Non-nucleoside reverse transcriptase inhibitor. Administered as film coated tablet.
Steady State Plasma Concentrations of Doravirine After Drug Intake Cessation up to 72h Post-dose Cmax 0-24h	1286 ng*hr/mL Interval 1162.0 to 1488.0
Steady State Plasma Concentrations of Doravirine After Drug Intake Cessation up to 72h Post-dose Cmax 0-72h	1286 ng*hr/mL Interval 1188.0 to 1462.0

PRIMARY outcome

Timeframe: 72 hours from treatment cessation; days 7-10 inclusive from enrolment

Population: Plasma concentrations of doravirine after drug intake cessation up to 72 hours post-dose were investigated in population of participants for the study

Following cessation of daily dorovirine, plasma concentrations of drug to be taken before last dose and at 11 further timepoints over 72 hours. Blood samples were collected pre-dose and at 2, 4, 8, 12, 24, 30, 36, 48, 60 and 72h post-dose

Outcome measures

Outcome measures
Measure	Study Intervention n=14 Participants Pifeltro® (doravirine 100mg) daily dose for 7 days Doravirine: Non-nucleoside reverse transcriptase inhibitor. Administered as film coated tablet.
Steady State Plasm Concentrations of Doravirine After Drug Intake Cessation up to 72 Hours Post-dose Ctrough at 24 h	420 ng*hr/mL Interval 373.0 to 526.0
Steady State Plasm Concentrations of Doravirine After Drug Intake Cessation up to 72 Hours Post-dose Ctrough at 72 h	39 ng*hr/mL Interval 33.0 to 61.0

PRIMARY outcome

Timeframe: 72 hours from treatment cessation; days 7-10 inclusive from enrolment

Population: Plasma concentrations of doravirine after drug intake cessation up to 72 hours post-dose were investigated in population of participants for the study

Following cessation of daily dorivirine, plasm concentrations of drug to be taken were collected pre-dose and at 2,4,8, 12, 24, 30, 36, 48, 60 and 72h post-dose

Outcome measures

Outcome measures
Measure	Study Intervention n=14 Participants Pifeltro® (doravirine 100mg) daily dose for 7 days Doravirine: Non-nucleoside reverse transcriptase inhibitor. Administered as film coated tablet.
Steady State Plasma Concentrations of Doravirine After Drug Intake Cessation up to 72 Hours Post-dose. t1/2 0-24h	14.56 ng*hr/mL Interval 13.19 to 16.59
Steady State Plasma Concentrations of Doravirine After Drug Intake Cessation up to 72 Hours Post-dose. t1/2 0-72h	13.97 ng*hr/mL Interval 12.77 to 15.68

SECONDARY outcome

Timeframe: From enrolment to last visit; last visit will be between days 20-23 from enrolment

Population: Safety and tolerability of study drug were investigated in population of participants for the study

All adverse events to be recorded and reported during the study up to last visit.

Outcome measures

Outcome measures
Measure	Study Intervention n=14 Participants Pifeltro® (doravirine 100mg) daily dose for 7 days Doravirine: Non-nucleoside reverse transcriptase inhibitor. Administered as film coated tablet.
Number of Participants With Treatment-emergent Adverse Events Hay Fever	4 Participants
Number of Participants With Treatment-emergent Adverse Events Headache	2 Participants
Number of Participants With Treatment-emergent Adverse Events No adverse events	8 Participants

Adverse Events

Study Intervention

Serious events: 0 serious events

Other events: 6 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Study Intervention n=14 participants at risk Pifeltro® (doravirine 100mg) daily dose for 7 days Doravirine: Non-nucleoside reverse transcriptase inhibitor. Administered as film coated tablet.
Infections and infestations Hay fever	28.6% 4/14 • Number of events 4 • Safety and tolerability of the studied drug was collected over a period of 23 days. All adverse events, however minor, were documented in the CRF whether or not the Investigator concludes the event to be related to drug treatment.
Nervous system disorders Headaches	14.3% 2/14 • Number of events 2 • Safety and tolerability of the studied drug was collected over a period of 23 days. All adverse events, however minor, were documented in the CRF whether or not the Investigator concludes the event to be related to drug treatment.

Additional Information

Research Operations Manager

Chelsea and Westminster NHS Foundation Trust

Phone: +442033156825

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place