A Crossover Study to Evaluate the Bioavailability of Ibrutinib Suspension and Sprinkle Formulations Compared to Capsules in Healthy Adults

Sponsor
Janssen Research & Development, LLC
Study ID
NCT02390609
Phase
PHASE1
Status
Completed

Conditions

  • Healthy

Eligibility Criteria

Sex
ALL
Age
18 Years - 55 Years
Healthy Volunteers
Accepted

Interventions

  • Ibrutinib (Treatment A) [Reference] — DRUG
    Participants will receive Ibrutinib 560 milligram (mg) (4\*140 mg) capsule as Treatment A under fasted conditions in one of the treatment periods.
  • Ibrutinib (Treatment B) — DRUG
    Participants will receive Ibrutinib 560 mg suspension as Treatment B under fasted conditions in one of the treatment periods.
  • Ibrutinib (Treatment C) — DRUG
    Participants will receive Ibrutinib 560 mg suspension as Treatment C under fed (high-fat) conditions in one of the treatment periods.
  • Ibrutinib (Treatment D) — DRUG
    Participants will receive Ibrutinib 560 mg sprinkle capsule granules as Treatment D under fasted conditions in one of the treatment periods.
  • Ibrutinib (Treatment E) — DRUG
    Participants will receive Ibrutinib 560 mg sprinkle capsule granules as Treatment E under fed (high-fat) conditions in one of the treatment periods.
  • Ibrutinib (Treatment F) — DRUG
    Participants will receive Ibrutinib 560 mg sprinkle capsule granules suspended in water as Treatment F under fasted conditions in one of the treatment periods.

Study Details

The purpose of this study is to assess the relative bioavailability (the extent to which a drug or other substance becomes available to the body) of ibrutinib in healthy adults following single oral dose administration of suspension and sprinkle formulations under fed and fasted conditions compared with capsules under fasted conditions.

Key Dates

Start date
Mar 31, 2015
Status verified
Dec 2015
Primary completion
Nov 30, 2015
Completion
Nov 30, 2015

Study Design

Enrollment
40 participants (actual)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT

Arms

  • Experimental: Group 1: Sequence 1 (ABC)
    Participants will receive Treatment A (Ibrutinib 560 milligram \[mg\] capsules \[reference\] under fasted conditions) in Period 1; followed by Treatment B (Ibrutinib 560 mg suspension under fasted conditions) in Period 2; followed by Treatment C (Ibrutinib 560 mg suspension under fed conditions) in Period 3. A washout period of 7 (plus \[+\] / minus \[-\] 2) days will be maintained between each treatment period.
  • Experimental: Group 1: Sequence 2 (BCA)
    Participants will receive Treatment B (Ibrutinib 560 mg suspension under fasted conditions) in Period 1; followed by Treatment C (Ibrutinib 560 mg suspension under fed conditions) in Period 2; followed by Treatment A (Ibrutinib 560 mg capsules \[reference\] under fasted conditions) in Period 3. A washout period of 7 (+/- 2) days will be maintained between each treatment period.
  • Experimental: Group 1: Sequence 3 (CAB)
    Participants will receive Treatment C (Ibrutinib 560 mg suspension under fed conditions) in Period 1; followed by Treatment A (Ibrutinib 560 mg capsules \[reference\] under fasted conditions) in Period 2; followed by Treatment B (Ibrutinib 560 mg suspension under fasted conditions) in Period 3. A washout period of 7 (+/- 2) days will be maintained between each treatment period.
  • Experimental: Group 1: Sequence 4 (ACB)
    Participants will receive Treatment A (Ibrutinib 560 mg capsules \[reference\] under fasted conditions) in Period 1; followed by Treatment C (Ibrutinib 560 mg suspension under fed conditions) in Period 2; followed by Treatment B (Ibrutinib 560 mg suspension under fasted conditions) in Period 3. A washout period of 7 (+/- 2) days will be maintained between each treatment period.
  • Experimental: Group 1: Sequence 5 (BAC)
    Participants will receive Treatment B (Ibrutinib 560 mg suspension under fasted conditions) in Period 1; followed by Treatment A (Ibrutinib 560 mg capsules \[reference\] under fasted conditions) in Period 2; followed by Treatment C (Ibrutinib 560 mg suspension under fed conditions) in Period 3. A washout period of 7 (+/- 2) days will be maintained between each treatment period.
  • Experimental: Group 1: Sequence 6 (CBA)
    Participants will receive Treatment C (Ibrutinib 560 mg suspension under fed conditions) in Period 1; followed by Treatment B (Ibrutinib 560 mg suspension under fasted conditions) in Period 2; followed by Treatment A (Ibrutinib 560 mg capsules \[reference\] under fasted conditions) in Period 3. A washout period of 7 (+/- 2) days will be maintained between each treatment period.
  • Experimental: Group 2: Sequence 1 (AFDE)
    Participants will receive Treatment A (Ibrutinib 560 mg capsules \[reference\] under fasted conditions) in Period 1; followed by Treatment F (Ibrutinib 560 mg sprinkle capsule granules suspended in water under fasted conditions) in Period 2; followed by Treatment D (Ibrutinib 560 mg sprinkle capsule granules under fasted conditions) in Period 3; followed by Treatment E (Ibrutinib 560 mg sprinkle capsule granules under fed conditions) in Period 4. A washout period of 7 (+/- 2) days will be maintained between each treatment period.
  • Experimental: Group 2: Sequence 2 (DAEF)
    Participants will receive Treatment D (Ibrutinib 560 mg sprinkle capsule granules under fasted conditions) in Period 1; followed by Treatment A (Ibrutinib 560 mg capsules \[reference\] under fasted conditions) in Period 2; followed by Treatment E (Ibrutinib 560 mg sprinkle capsule granules under fed conditions) in Period 3; followed by Treatment F (Ibrutinib 560 mg sprinkle capsule granules suspended in water under fasted conditions) in Period 4. A washout period of 7 (+/- 2) days will be maintained between each treatment period.
  • Experimental: Group 2: Sequence 3 (EDFA)
    Participants will receive Treatment E (Ibrutinib 560 mg sprinkle capsule granules under fed conditions) in Period 1; followed by Treatment D (Ibrutinib 560 mg sprinkle capsule granules under fasted conditions) in Period 2; followed by Treatment F (Ibrutinib 560 mg sprinkle capsule granules suspended in water under fasted conditions) in Period 3; followed by Treatment A (Ibrutinib 560 mg capsules \[reference\] under fasted conditions) in Period 4. A washout period of 7 (+/- 2) days will be maintained between each treatment period.
  • Experimental: Group 2: Sequence 4 (FEAD)
    Participants will receive Treatment F (Ibrutinib 560 mg sprinkle capsule granules suspended in water under fasted conditions) in Period 1; followed by Treatment E (Ibrutinib 560 mg sprinkle capsule granules under fed conditions) in Period 2; followed by Treatment A (Ibrutinib 560 mg capsules \[reference\] under fasted conditions) in Period 3; followed by Treatment D (Ibrutinib 560 mg sprinkle capsule granules under fasted conditions) in Period 4. A washout period of 7 (+/- 2) days will be maintained between each treatment period.

Primary Outcome Measure

Maximum Plasma Concentration (Cmax) of Ibrutinib [ Time Frame: Pre-dose; 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36 and 48 hours post-dose on Day 1 of each period ]

Related Studies