Trial Outcomes & Findings for The Raltegravir and Ribavirin Pharmacokinetics (PK) Study (NCT NCT00982553)

Results Overview

Pharmacokinetic analyses of blood samples

Recruitment status

COMPLETED

Study phase

PHASE1

Target enrollment

14 participants

Primary outcome timeframe

Day 20

Results posted on

2019-10-11

Participant Flow

* Recruitment was between 24/09/2009 and 29/10/2009. * 14 subjects were enrolled. * The study took place at a specialist research unit at an National Health Service (NHS) hospital.

* Subjects were healthy volunteers. * There was a 21 day washout for any prescribed and 7 days for over the counter medication before enrolment. * The subjects were permitted to take paracetamol during the study but all others were excluded for the duration of the trial.

Participant milestones

Participant milestones
Measure	All Subjects All subjects received the same study therapy as follows: Day 1 Ribavirin single dose 800 mg oral followed by intensive PK monitoring. Day 2 - 14 washout phase Day 15 - 18 raltegravir 400 mg twice daily followed by by intensive PK monitoring on day 18. Day 19 raltegravir 400 mg plus ribavirin 800 mg by intensive PK monitoring.
Phase1 STARTED	14
Phase1 COMPLETED	14
Phase1 NOT COMPLETED	0
Phase2 STARTED	14
Phase2 COMPLETED	14
Phase2 NOT COMPLETED	0
Phase3 STARTED	14
Phase3 COMPLETED	14
Phase3 NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

The Raltegravir and Ribavirin Pharmacokinetics (PK) Study

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	All Subjects n=14 Participants All subjects received the same study therapy as follows: Day 1 Ribavirin single dose 800 mg oral followed by intensive PK monitoring. Day 2 - 14 washout phase Day 15 - 18 raltegravir 400 mg twice daily followed by by intensive PK monitoring on day 18. Day 19 raltegravir 400 mg plus ribavirin 800 mg by intensive PK monitoring.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	14 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age, Continuous	35 years STANDARD_DEVIATION 10 • n=5 Participants
Sex: Female, Male Female	4 Participants n=5 Participants
Sex: Female, Male Male	10 Participants n=5 Participants
Region of Enrollment United Kingdom	14 participants n=5 Participants

PRIMARY outcome

Timeframe: Day 20

Population: Per protocol

Pharmacokinetic analyses of blood samples

Outcome measures

Outcome measures
Measure	Phase1_ribavirin n=14 Participants Single dose ribavirin 800mg administered on day 1	Phase3_ribovarin and Raltegravir n=14 Participants Single dose ribavirin 800mg and raltegravir 400mg at day 20
Ribavirin Maximum Plasma Concentration	630.09 ng/mL Interval 490.91 to 808.54	496.71 ng/mL Interval 407.38 to 605.76

PRIMARY outcome

Timeframe: Day 20

Outcome measures

Outcome measures
Measure	Phase1_ribavirin n=14 Participants Single dose ribavirin 800mg administered on day 1	Phase3_ribovarin and Raltegravir n=14 Participants Single dose ribavirin 800mg and raltegravir 400mg at day 20
Raltegravir Maximum Plasma Concentration	2227.41 ng/mL Interval 1489.36 to 3331.19	2591.19 ng/mL Interval 1778.28 to 3774.85

PRIMARY outcome

Timeframe: Day 20

Ribavirin minimum plasma concentration by pharmacokinetic analyses

Outcome measures

Outcome measures
Measure	Phase1_ribavirin n=14 Participants Single dose ribavirin 800mg administered on day 1	Phase3_ribovarin and Raltegravir n=14 Participants Single dose ribavirin 800mg and raltegravir 400mg at day 20
Ribavirin Minimum Plasma Concentration	184.71 ng/mL Interval 148.59 to 229.61	186.98 ng/mL Interval 157.83 to 221.56

PRIMARY outcome

Timeframe: Day 20

Raltegravir minimum plasma concentrations by pharmacokinetic analyses

Outcome measures

Outcome measures
Measure	Phase1_ribavirin n=14 Participants Single dose ribavirin 800mg administered on day 1	Phase3_ribovarin and Raltegravir n=14 Participants Single dose ribavirin 800mg and raltegravir 400mg at day 20
Raltegravir Minimum Plasma Concentrations	83.97 ng/mL Interval 45.64 to 154.45	68.91 ng/mL Interval 40.74 to 116.55

Adverse Events

All Subjects

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 Alan Winston

Imperial College

Phone: +44 (0)20 3312 1603

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place