Trial Outcomes & Findings for Boceprevir and Ucalm (St John&Apos;s Wort) (NCT NCT01663922)

Last Updated: 2014-09-29

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE1

Target enrollment

17 participants

Primary outcome timeframe

6 months

Results posted on

2014-09-29

Participant Flow

All volunteers were recruited at a single centre, SSAT Research Unit, Chelsea \& Westminster Hospital, London, UK.

Eligible participants took: SJW for 14 days Group A D1-D14 or boceprevir(BCP) for 5 D10-D14 days Group B (D 10-14); PK profile on D14 then 7 day washout period to D21 D22-D35, all took SJW (+ BCP on D31-D35); PK on D35 then washout to D42 Group A took BCP on D52-D56; Group B SJW on D43-D56; PK profile on D56.

Participant milestones

Participant milestones
Measure	Group A (St John's Wort Then Boceprevir) * 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 B (Boceprevir Then St John's Wort) * 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
First Intervention (14 Days or 5 Days) STARTED	8	9
First Intervention (14 Days or 5 Days) COMPLETED	8	9
First Intervention (14 Days or 5 Days) NOT COMPLETED	0	0
Washout (7 Days) STARTED	8	9
Washout (7 Days) COMPLETED	8	9
Washout (7 Days) NOT COMPLETED	0	0
Second Intervention (14 Days) STARTED	8	9
Second Intervention (14 Days) COMPLETED	8	9
Second Intervention (14 Days) NOT COMPLETED	0	0
Third Intervention (14 Days or 5 Days) STARTED	8	9
Third Intervention (14 Days or 5 Days) COMPLETED	8	9
Third Intervention (14 Days or 5 Days) NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	All Participants n=17 Participants Descriptive analysis of combined groups
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	17 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Sex: Female, Male Female	11 Participants n=5 Participants
Sex: Female, Male Male	6 Participants n=5 Participants
Region of Enrollment United Kingdom	17 participants n=5 Participants

PRIMARY outcome

Timeframe: 6 months

Population: All participants who completed the three PK assessments were included in the analysis. BCP metabolites (SCH534128 \& SCH523129) PK parameters were determined in the presence and absence of SJW, and hypericin PK parameters in the presence and absence of BCP; for the total study population.

Outcome measures

Outcome measures
Measure	All Participants n=17 Participants Combined analysis of both group sequences
Pharmacokinetic of Boceprevir in the Presence of Ucalm (St John's Wort) Total Boceprevir alone	4588 ng*h/mL Interval 4160.0 to 5317.0
Pharmacokinetic of Boceprevir in the Presence of Ucalm (St John's Wort) Boceprevir in presence of St Johns Wort)	4204 ng*h/mL Interval 3785.0 to 4886.0
Pharmacokinetic of Boceprevir in the Presence of Ucalm (St John's Wort) Hypericin alone	11.6 ng*h/mL Interval 9.3 to 17.0
Pharmacokinetic of Boceprevir in the Presence of Ucalm (St John's Wort) Hypericin in presence of boceprevir	14.3 ng*h/mL Interval 11.2 to 20.8
Pharmacokinetic of Boceprevir in the Presence of Ucalm (St John's Wort) SCH534128 alone	3222 ng*h/mL Interval 2929.0 to 3687.0
Pharmacokinetic of Boceprevir in the Presence of Ucalm (St John's Wort) SCH534128 in presence of St. Johns Wort	2935 ng*h/mL Interval 2653.0 to 3687.0

Adverse Events

Group A

Serious events: 0 serious events

Other events: 6 other events

Deaths: 0 deaths

Group B

Serious events: 0 serious events

Other events: 9 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Group A n=8 participants at risk St John's Wort first	Group B n=9 participants at risk Boceprevir first
Nervous system disorders Headache	50.0% 4/8 • Number of events 5	33.3% 3/9 • Number of events 9
Respiratory, thoracic and mediastinal disorders coryzal symptoms	25.0% 2/8 • Number of events 2	44.4% 4/9 • Number of events 7
Psychiatric disorders Anxiety	12.5% 1/8 • Number of events 1	0.00% 0/9
Nervous system disorders nausea	12.5% 1/8 • Number of events 1	11.1% 1/9 • Number of events 1
Gastrointestinal disorders vomiting	0.00% 0/8	11.1% 1/9 • Number of events 1
Cardiac disorders pre-syncope	0.00% 0/8	11.1% 1/9 • Number of events 1
Reproductive system and breast disorders dysmenorrhoea	0.00% 0/8	22.2% 2/9 • Number of events 2
Musculoskeletal and connective tissue disorders arthralgia	0.00% 0/8	11.1% 1/9 • Number of events 1
Eye disorders conjunctival infection	0.00% 0/8	11.1% 1/9 • Number of events 1

Additional Information

Dr Akil Jackson

St Stephens AIDS Trust

Phone: 0203 315 6503

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place