D 1-14 St. John's Wort 2 x 300mg (Ucalm(r)) QD D 22-35 St. John's Wort 2 x 300mg (Ucalm(r)) QD D 31-35 Boceprevir 800mg tds D 52-56 Boceprevir 800mg tds

D 10-14 Boceprevir 800mg tds D 22-35 St. John's Wort 2 x 300mg (Ucalm(r)) QD D 31-35 Boceprevir 800mg tds D 43-56 St. John's Wort 2 x 300mg (Ucalm(r)) QD

All Participants

Sex: Female, Male

Region of Enrollment

Pharmacokinetic parameters (maximum and trough concentrations, and area under concentratof boceprevir and SJW will be evaluated when given in combination at steady-state to evaluate possible differences in concentrations during co-administration versus drug given alone.
The pharmacokinetic parameters calculated for boceprevir and SJW will be Ctrough,the maximum observed plasma concentration (Cmax), time point at Cmax (Tmax), and total drug exposure, expressed as the area under the plasma concentration-time curve.
All pharmacokinetic parameters will be calculated using non-compartmental modelling techniques (WinNonlin®) and all statistical calculations performed within-participant changes in the assessed pharmacokinetic parameters (drug alone vs drug combination) will be evaluated by calculating geometric mean ratios.

Combined analysis of both group sequences

Pharmacokinetic of Boceprevir in the Presence of Ucalm (St John's Wort)

St John's Wort, (SJW) for 14 days (1-14)
[wash out for 7 days (15-21)]
SJW for 14 days (22-35) plus boceprevir from day 31 to day 35 (5 days in total)
[wash out for 7 days (36-42)]
boceprevir from day 52 to day 56

Group A (St John's Wort Then Boceprevir)

Boceprevir for 5 days (10-14)
[wash out for 7 days (15-21)]
SJW for 14 days (22-35) plus boceprevir from day 31 to day 35 (5 days in total)
[wash out for 7 days (36-42)
SJW from day 43 to day 56

Group B (Boceprevir Then St John's Wort)

First Intervention (14 Days or 5 Days)

Washout (7 Days)

Second Intervention (14 Days)

Third Intervention (14 Days or 5 Days)

Dr Akil Jackson

Group A

Group B

Hepatitis C

Boceprevir as Victrelis(r) 200mg capsules

Boceprevir

Each Ucalm(r) tablet contains 300mg of St Johns Wort extract

St John's Wort

St Stephen's AIDS Trust

Boceprevir and Ucalm (St John&Apos;s Wort)

Phase I Evaluation of the Pharmacokinetics and Safety of Boceprevir and Ucalm (St John&Apos;s Wort) When Co-administered to Male and Female Healthy Volunteers.

ergonovine/breast neoplasms

Boceprevir and Ucalm (St John&Apos;s Wort)

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