Trial Outcomes & Findings for The Boceprevir and Sildenafil Pharmacokinetics Study (NCT NCT01499498)

Results Overview

Single dose sildenafil 25mg will be administered with food. Intensive pharmacokinetic sampling will be taken over a 24 hour period (0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12 and 24 hours post dose)

Recruitment status

COMPLETED

Study phase

PHASE1

Target enrollment

13 participants

Primary outcome timeframe

Day 1

Results posted on

2019-06-21

Participant Flow

Participant milestones

Participant milestones
Measure	Sildenafil and Boceprevir Healthy volunteers Sildenafil and Boceprevir : 25mg once daily/800mg three times a day
Overall Study STARTED	13
Overall Study COMPLETED	13
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

The Boceprevir and Sildenafil Pharmacokinetics Study

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Sildenafil and Boceprevir n=13 Participants All subjects take single dose sildenafil 25mg day 0, day 10-15 they take boceprevir 800mg three times a day followed by Intentive PK on day 15 and on day 16 single dose of sildenafil and boceprevir together followed by intensive PK
Age, Continuous	36 years n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants
Sex: Female, Male Male	13 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	4 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	3 Participants n=5 Participants
Race (NIH/OMB) White	6 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Body Mass Index	26.2 kg/m2 n=5 Participants

PRIMARY outcome

Timeframe: Day 1

Single dose sildenafil 25mg will be administered with food. Intensive pharmacokinetic sampling will be taken over a 24 hour period (0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12 and 24 hours post dose)

Outcome measures

Outcome measures
Measure	Sildenafil Only n=13 Participants Healthy volunteers Sildenafil 25mg once
Sildenafil Alone Maximum Plasma Concentration	79.9 ng/mL Interval 59.9 to 106.5

PRIMARY outcome

Timeframe: day 10-15

Day 10 commence BOC 800mg three times a day with food. On day 15 at steady state, subjects will attend for witnessed dosing and an intensive pharmacokinetic visit over 8 hours (samples drawn 0, 0.5, 1, 2, 3, 4, 6 and 8 hours post dose)

Outcome measures

Outcome measures
Measure	Sildenafil Only n=13 Participants Healthy volunteers Sildenafil 25mg once
Boceprevir Alone Maximum Plasma Concentration	1432.5 ng/mL Interval 1276.1 to 1607.7

PRIMARY outcome

Timeframe: Day 16

administer BOC 800mg and single dose sildenafil 25mg with food. Intensive pharmacokinetic sampling will be taken over a 24 hour period (0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12 and 24 hours post dose)

Outcome measures

Outcome measures
Measure	Sildenafil Only n=13 Participants Healthy volunteers Sildenafil 25mg once
Sildenafil Maximum Plasma Concentration	150.9 ng/mL Interval 126.2 to 180.5

PRIMARY outcome

Timeframe: Day 16

administer BOC 800mg and single dose sildenafil 25mg with food. Intensive pharmacokinetic sampling will be taken over a 24 hour period (0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12 and 24 hours post dose)

Outcome measures

Outcome measures
Measure	Sildenafil Only n=13 Participants Healthy volunteers Sildenafil 25mg once
Boceprevir Maximum Plasma Concentration	1440.5 ng/mL Interval 1211.7 to 1712.4

SECONDARY outcome

Timeframe: Day 1 - 16

The number of repeated adverse events will be used to assess the safety of the drugs in combination

Outcome measures

Outcome measures
Measure	Sildenafil Only n=13 Participants Healthy volunteers Sildenafil 25mg once
Number of Patients With Adverse Events	0 participants

Adverse Events

Sildenafil and Boceprevir

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr Borja Mora Peris

Imperial College London

Phone: 020 3312 6789

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place