A Crossover Study to Evaluate Relative Bioavailability of Simeprevir Age-appropriate Oral Formulation Candidates Compared With 150-milligram (mg) Oral Capsule in Healthy Adult Participants
NCT ID: NCT02385071
Last Updated: 2017-09-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
48 participants
INTERVENTIONAL
2015-04-28
2015-09-09
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
NONE
Study Groups
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Panel1: Sequence 1 (ABC)
Participants will receive Treatment A (150 milligram (mg) simeprevir (SMV) capsule with water under fed conditions) in Period 1; followed by Treatment B (3\*50 mg capsules of SMV \[including 50 mini-tablets of 1 mg each\] with water under fed conditions) in Period 2; followed by Treatment C (3\*50 mg dispersible SMV tablets dispersed in water under fed conditions) in Period 3. A washout period of at least 7 days will be maintained between each treatment period.
Treatment A
150 milligram (mg) SMV capsule with water under fed conditions.
Treatment B
Treatment B (3\*50 mg capsules of SMV (including 50 mini-tablets of 1 mg each) with water under fed conditions.
Treatment C
Treatment C (3\*50 mg dispersible SMV tablets dispersed in water under fed conditions).
Panel1: Sequence 2 (BCA)
Participants will receive Treatment B in Period 1; followed by Treatment C in Period 2; followed by Treatment A in Period 3. A washout period of at least 7 days will be maintained between each treatment period.
Treatment A
150 milligram (mg) SMV capsule with water under fed conditions.
Treatment B
Treatment B (3\*50 mg capsules of SMV (including 50 mini-tablets of 1 mg each) with water under fed conditions.
Treatment C
Treatment C (3\*50 mg dispersible SMV tablets dispersed in water under fed conditions).
Panel1: Sequence 3 (CAB)
Participants will receive Treatment C in Period 1; followed by Treatment A in Period 2; followed by Treatment B in Period 3. A washout period of at least 7 days will be maintained between each treatment period.
Treatment A
150 milligram (mg) SMV capsule with water under fed conditions.
Treatment B
Treatment B (3\*50 mg capsules of SMV (including 50 mini-tablets of 1 mg each) with water under fed conditions.
Treatment C
Treatment C (3\*50 mg dispersible SMV tablets dispersed in water under fed conditions).
Panel1: Sequence 4 (CBA)
Participants will receive Treatment C in Period 1; followed by Treatment B in Period 2; followed by Treatment A in Period 3. A washout period of at least 7 days will be maintained between each treatment period.
Treatment A
150 milligram (mg) SMV capsule with water under fed conditions.
Treatment B
Treatment B (3\*50 mg capsules of SMV (including 50 mini-tablets of 1 mg each) with water under fed conditions.
Treatment C
Treatment C (3\*50 mg dispersible SMV tablets dispersed in water under fed conditions).
Panel1: Sequence 5 (BAC)
Participants will receive Treatment B in Period 1; followed by Treatment A in Period 2; followed by Treatment C in Period 3. A washout period of at least 7 days will be maintained between each treatment period.
Treatment A
150 milligram (mg) SMV capsule with water under fed conditions.
Treatment B
Treatment B (3\*50 mg capsules of SMV (including 50 mini-tablets of 1 mg each) with water under fed conditions.
Treatment C
Treatment C (3\*50 mg dispersible SMV tablets dispersed in water under fed conditions).
Panel1: Sequence 6 (ACB)
Participants will receive Treatment A in Period 1; followed by Treatment C in Period 2; followed by Treatment B in Period 3. A washout period of at least 7 days will be maintained between each treatment period.
Treatment A
150 milligram (mg) SMV capsule with water under fed conditions.
Treatment B
Treatment B (3\*50 mg capsules of SMV (including 50 mini-tablets of 1 mg each) with water under fed conditions.
Treatment C
Treatment C (3\*50 mg dispersible SMV tablets dispersed in water under fed conditions).
Panel 2: Sequence 1 (DEF)
Participants will receive Treatment D (3\*50 mg SMV capsules \[including 50 mini-tablets of 1 mg each\] with water or 3\*50 mg dispersible SMV tablets dispersed in water under fed conditions) in Period 1; followed by Treatment E (3\*50 mg SMV capsules \[including 50 mini-tablets of 1 mg each\] with water or 3\*50 mg dispersible SMV tablets dispersed in water under fasted conditions) in Period 2; followed by Treatment F (3\*50 mg SMV capsules \[including 50 mini-tablets of 1 mg each\] with yoghurt or 3\*50 mg dispersible SMV tablets dispersed in apple juice under fed conditions) in Period 3. A washout period of at least 7 days will be maintained between each treatment period.
Treatment D
\*50 mg SMV capsules (including 50 mini-tablets of 1 mg each) with water or 3\*50 mg dispersible SMV tablets dispersed in water under fed conditions.
Treatment E
3\*50 mg SMV capsules (including 50 mini-tablets of 1 mg each) with water or 3\*50 mg dispersible SMV tablets dispersed in water under fasted conditions.
Treatment F
3\*50 mg SMV capsules (including 50 mini-tablets of 1 mg each) with yoghurt or 3\*50 mg dispersible SMV tablets dispersed in apple juice under fed conditions.
Panel 2: Sequence 2 (EFD)
Participants will receive Treatment E in Period 1; followed by Treatment F in Period 2; followed by Treatment D in Period 3. A washout period of at least 7 days will be maintained between each treatment period.
Treatment D
\*50 mg SMV capsules (including 50 mini-tablets of 1 mg each) with water or 3\*50 mg dispersible SMV tablets dispersed in water under fed conditions.
Treatment E
3\*50 mg SMV capsules (including 50 mini-tablets of 1 mg each) with water or 3\*50 mg dispersible SMV tablets dispersed in water under fasted conditions.
Treatment F
3\*50 mg SMV capsules (including 50 mini-tablets of 1 mg each) with yoghurt or 3\*50 mg dispersible SMV tablets dispersed in apple juice under fed conditions.
Panel 2: Sequence 3 (FDE)
Participants will receive Treatment F in Period 1; followed by Treatment D in Period 2; followed by Treatment E in Period 3. A washout period of at least 7 days will be maintained between each treatment period.
Treatment D
\*50 mg SMV capsules (including 50 mini-tablets of 1 mg each) with water or 3\*50 mg dispersible SMV tablets dispersed in water under fed conditions.
Treatment E
3\*50 mg SMV capsules (including 50 mini-tablets of 1 mg each) with water or 3\*50 mg dispersible SMV tablets dispersed in water under fasted conditions.
Treatment F
3\*50 mg SMV capsules (including 50 mini-tablets of 1 mg each) with yoghurt or 3\*50 mg dispersible SMV tablets dispersed in apple juice under fed conditions.
Panel 2: Sequence 4 (FED)
Participants will receive Treatment F in Period 1; followed by Treatment E in Period 2; followed by Treatment D in Period 3. A washout period of at least 7 days will be maintained between each treatment period.
Treatment D
\*50 mg SMV capsules (including 50 mini-tablets of 1 mg each) with water or 3\*50 mg dispersible SMV tablets dispersed in water under fed conditions.
Treatment E
3\*50 mg SMV capsules (including 50 mini-tablets of 1 mg each) with water or 3\*50 mg dispersible SMV tablets dispersed in water under fasted conditions.
Treatment F
3\*50 mg SMV capsules (including 50 mini-tablets of 1 mg each) with yoghurt or 3\*50 mg dispersible SMV tablets dispersed in apple juice under fed conditions.
Panel 2: Sequence 5 (EDF)
Participants will receive Treatment E in Period 1; followed by Treatment D in Period 2; followed by Treatment F in Period 3. A washout period of at least 7 days will be maintained between each treatment period.
Treatment D
\*50 mg SMV capsules (including 50 mini-tablets of 1 mg each) with water or 3\*50 mg dispersible SMV tablets dispersed in water under fed conditions.
Treatment E
3\*50 mg SMV capsules (including 50 mini-tablets of 1 mg each) with water or 3\*50 mg dispersible SMV tablets dispersed in water under fasted conditions.
Treatment F
3\*50 mg SMV capsules (including 50 mini-tablets of 1 mg each) with yoghurt or 3\*50 mg dispersible SMV tablets dispersed in apple juice under fed conditions.
Panel 2: Sequence 6 (DFE)
Participants will receive Treatment D in Period 1; followed by Treatment F in Period 2; followed by Treatment E in Period 3. A washout period of at least 7 days will be maintained between each treatment period.
Treatment D
\*50 mg SMV capsules (including 50 mini-tablets of 1 mg each) with water or 3\*50 mg dispersible SMV tablets dispersed in water under fed conditions.
Treatment E
3\*50 mg SMV capsules (including 50 mini-tablets of 1 mg each) with water or 3\*50 mg dispersible SMV tablets dispersed in water under fasted conditions.
Treatment F
3\*50 mg SMV capsules (including 50 mini-tablets of 1 mg each) with yoghurt or 3\*50 mg dispersible SMV tablets dispersed in apple juice under fed conditions.
Interventions
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Treatment A
150 milligram (mg) SMV capsule with water under fed conditions.
Treatment B
Treatment B (3\*50 mg capsules of SMV (including 50 mini-tablets of 1 mg each) with water under fed conditions.
Treatment C
Treatment C (3\*50 mg dispersible SMV tablets dispersed in water under fed conditions).
Treatment D
\*50 mg SMV capsules (including 50 mini-tablets of 1 mg each) with water or 3\*50 mg dispersible SMV tablets dispersed in water under fed conditions.
Treatment E
3\*50 mg SMV capsules (including 50 mini-tablets of 1 mg each) with water or 3\*50 mg dispersible SMV tablets dispersed in water under fasted conditions.
Treatment F
3\*50 mg SMV capsules (including 50 mini-tablets of 1 mg each) with yoghurt or 3\*50 mg dispersible SMV tablets dispersed in apple juice under fed conditions.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Participants must be willing and able to adhere to the prohibitions and restrictions specified in the protocol and study procedures
* Female participants, except for postmenopausal women, should have a negative serum pregnancy test at screening
* All female participants should have a negative urine pregnancy test on Day -1 of the first treatment session
* Male participants heterosexually active with a woman of childbearing potential must agree to use two effective methods of birth control and all men must not donate sperm during the study and for at least 30 days after receiving the last dose of study drug
Exclusion Criteria
* Participants with current hepatitis A infection (confirmed by hepatitis A antibody immunoglobulin \[IgM\]), or hepatitis B infection (confirmed by hepatitis B surface antigen \[HBsAg\]), or hepatitis C infection (confirmed by HCV antibody), or human immunodeficiency virus type 1 (HIV-1) or HIV-2 infection
* Participants with a history or evidence of current or past abuse of alcohol, or recreational or narcotic drugs, which in the Investigator's opinion would compromise the participant's safety and/or compliance with the study procedures
* Participants with any history of clinically relevant skin disease such as, but not limited to, dermatitis, eczema, drug rash, psoriasis, food allergy, and urticaria
* Participants with known allergies, hypersensitivity, or intolerance to simeprevir (SMV) or any of the excipients
18 Years
55 Years
ALL
Yes
Sponsors
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Janssen Sciences Ireland UC
INDUSTRY
Responsible Party
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Principal Investigators
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Janssen Sciences Ireland UC Clinical Trial
Role: STUDY_DIRECTOR
Janssen Sciences Ireland UC
Locations
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Harrow, , United Kingdom
Countries
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Other Identifiers
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TMC435HPC1010
Identifier Type: OTHER
Identifier Source: secondary_id
2014-005448-17
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
CR106516
Identifier Type: -
Identifier Source: org_study_id
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