HealthyPhase 1NCT02385071
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
A Phase 1 study testing Treatment A, Treatment B and Treatment C in people with Healthy, run by Janssen Sciences Ireland UC at 1 site in United Kingdom.
Trial summary
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 simeprevir (SMV) following single dose administration of age-appropriate oral formulation candidates compared to the 150 milligram (mg) capsule, and to assess the effect… Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Treatment A, Treatment B and Treatment C
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 28 Apr 2015to 9 Sep 2015
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Participants must be healthy on the basis of physical examination, medical history, 12-lead electrocardiogram (ECG) and vital signs performed at screening (after signing the ICF), and on Day -1 of the first treatment session, if applicable. If there are abnormalities, the participant may be included only if the Investigator judges the abnormalities or deviations from normal to be not clinically significant. This determination must be recorded in the participant's source documents
- 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
Who cannot join
- Female participants who are pregnant or breast feeding at screening or on Day -1 of the first treatment session
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1, Open-label, Randomized, 2-panel, 3-way Crossover Study in Healthy Adult Subjects to Assess the Relative Bioavailability of Simeprevir Following Single Dose Administration of Age-appropriate Oral Formulation Candidates, Compared to the 150-mg Oral Capsule, and to Assess the Effect of Food on the Bioavailability of Simeprevir Following Single Dose Administration of a Selected Age-appropriate Oral Formulation Candidate
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 simeprevir (SMV) following single dose administration of age-appropriate oral formulation candidates compared to the 150 milligram (mg) capsule, and to assess the effect of food on the bioavailability of SMV following single dose administration of a selected age-appropriate oral formulation candidate.
Read the detailed description
This is a Phase 1, open-label (all people know the identity of the intervention), randomized (study medication assigned to participants by chance), 2-panel, 3-way crossover (participants will receive different interventions sequentially during the trial) study in healthy adult participants. Participants will be equally divided over 2 panels, and will not be randomized between panels. Participants will not be allowed to switch panels. The study consists of 3 parts: Screening Phase (that is, 28 days before study commences on Day 1); Open-label Treatment (in subsequent 3-treatment periods in each Panel, each separated with washout period of 7 days); and Post-Treatment Phase (up to 7 days after last study drug intake). The duration of the study per participant will be at least 19 days, screening and follow-up not included. All the eligible participants will be randomly assigned to 1 of the 6 treatment sequences in each Panel. In fasted conditions, study drug will be administered following a 10-hour overnight fast. In fed conditions, participants will also fast from food for 10 hours, but will consume a high fat/high calorie breakfast within a 30-minute period. Study drug will be administered 30 minutes after the start of breakfast. Participants will not be allowed to have food until at least 4 hours after study drug administration. Blood samples will be collected for evaluation of pharmacokinetics at pre-dose and post-dose of study treatment. Relative bioavailability of SMV formulations will be evaluated primarily. Participants' safety will be monitored throughout the study.
- Conditions
- Healthy
- Being tested
- Treatment A, Treatment B, Treatment C, Treatment D, Treatment E
- Keywords
- Healthy, Simeprevir, Bioavailability
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Treatment ADrug
Also called simeprevir
150 milligram (mg) SMV capsule with water under fed conditions.
Treatment BDrug
Also called simeprevir
Treatment B (3*50 mg capsules of SMV (including 50 mini-tablets of 1 mg each) with water under fed conditions.
Treatment CDrug
Also called simeprevir
Treatment C (3*50 mg dispersible SMV tablets dispersed in water under fed conditions).
Treatment DDrug
Also called simeprevir
*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 EDrug
Also called simeprevir
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 FDrug
Also called simeprevir
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.
| Study group | Role | What they receive |
|---|---|---|
| Panel1: Sequence 1 (ABC) | Experimental | 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. Receives: Drug: Treatment A; Drug: Treatment B; Drug: Treatment C |
| Panel1: Sequence 2 (BCA) | Experimental | 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. Receives: Drug: Treatment A; Drug: Treatment B; Drug: Treatment C |
| Panel1: Sequence 3 (CAB) | Experimental | 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. Receives: Drug: Treatment A; Drug: Treatment B; Drug: Treatment C |
| Panel1: Sequence 4 (CBA) | Experimental | 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. Receives: Drug: Treatment A; Drug: Treatment B; Drug: Treatment C |
| Panel1: Sequence 5 (BAC) | Experimental | 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. Receives: Drug: Treatment A; Drug: Treatment B; Drug: Treatment C |
| Panel1: Sequence 6 (ACB) | Experimental | 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. Receives: Drug: Treatment A; Drug: Treatment B; Drug: Treatment C |
| Panel 2: Sequence 1 (DEF) | Experimental | 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. Receives: Drug: Treatment D; Drug: Treatment E; Drug: Treatment F |
| Panel 2: Sequence 2 (EFD) | Experimental | 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. Receives: Drug: Treatment D; Drug: Treatment E; Drug: Treatment F |
| Panel 2: Sequence 3 (FDE) | Experimental | 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. Receives: Drug: Treatment D; Drug: Treatment E; Drug: Treatment F |
| Panel 2: Sequence 4 (FED) | Experimental | 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. Receives: Drug: Treatment D; Drug: Treatment E; Drug: Treatment F |
| Panel 2: Sequence 5 (EDF) | Experimental | 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. Receives: Drug: Treatment D; Drug: Treatment E; Drug: Treatment F |
| Panel 2: Sequence 6 (DFE) | Experimental | 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. Receives: Drug: Treatment D; Drug: Treatment E; Drug: Treatment F |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum Plasma Concentration (Cmax) of Simeprevir (SMV)
The Cmax is the maximum observed plasma concentration of SMV.
Measured: Baseline up to 72 hours post-administration of study drug
Time to Reach the Maximum Plasma Concentration (Tmax) of SMV
The Tmax is the time to reach the maximum observed plasma concentration of SMV.
Measured: Baseline up to 72 hours post-administration of study drug
Area Under the Plasma Concentration-Time Curve From 0 to last (AUC[0-last]) Post Dose of SMV
AUC (0-last) from time 0 to the time of the last measurable (non-below quantification limit [BQL]) concentration, calculated by linear-linear trapezoidal summation.
Measured: Baseline up to 72 hours post-administration of study drug
Area Under the Plasma Concentration-Time Curve From 0 to Infinite Time (AUC[0-infinity]) Post Dose of SMV
The AUC (0-infinity) is the area under the plasma concentration-time curve from time 0 to infinite time, calculated as the sum of AUC (0-last) and C(last)/lambda(z), in which AUC(0-last) is area under the plasma concentration-time curve from time zero to time of the last quantifiable concentration, C(last) is the last observed quantifiable concentration and lambda(z) is elimination rate constant.
Measured: Baseline up to 72 hours post-administration of study drug
Elimination Rate Constant (Lambda [z]) of SMV
The Lambda (z) determined by linear regression of the terminal points of the ln-linear plasma concentration-time curve.
Measured: Baseline up to 72 hours post-administration of study drug
Terminal Half-life (t[1/2]) of SMV
The t(1/2) is defined as 0.693/Lambda (z).
Measured: Baseline up to 72 hours post-administration of study drug
Secondary outcomes (2)
Number of Participants within Each Category of Taste Questionnaire
Participants will assess the palatability of the SMV formulations by Taste Questionnaire, Question 1 will assess sweetness, bitterness, flavor and overall taste of the formulation; and Question 2 consists of visual analog scale wherein participants will put a cross in the box beneath the scores, corresponding to the 5-point hedonic scale (dislike it very much; dislike it a little; not sure, like it a little, like it very much).
Measured: 5 to 15 minutes post administration of study drug (up to Day 19)
Number of Participants with Adverse Events (AEs) and Serious AEs
An adverse event (AE) is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A serious adverse event (SAE) is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.
Measured: Screening up to follow-up (7 days after last dose administration)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2015 (estimated)
- Study start28 Apr 2015
- Primary completion9 Sep 2015
- Study completion9 Sep 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Janssen Sciences Ireland UC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Janssen Sciences Ireland UC Clinical Trial, Study director, Janssen Sciences Ireland UC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02385071
- Sponsor's protocol ID
- CR106516
- Other IDs
- TMC435HPC1010, 2014-005448-17, 2014
- Status last verified
- Sep 2017
- First submitted
- 5 Mar 2015
- Last updated
- 7 Sep 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Open-label, Randomized, 2-panel, 3-way Crossover Study in Healthy Adult Subjects to Assess the Relative Bioavailability of Simeprevir Following Single Dose Administration of Age-appropriate Oral Formulation Candidates, Compared to the 150-mg Oral Capsule, and to Assess the Effect of Food on the Bioavailability of Simeprevir Following Single Dose Administration of a Selected Age-appropriate Oral Formulation Candidate
- ClinicalTrials.gov ID
- NCT02385071
- Acronym / sponsor ID
- CR106516
- Conditions
- Healthy
- Keywords
- Healthy, Simeprevir, Bioavailability
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Janssen Sciences Ireland UCIndustry (pharma, biotech, devices)
- Study start
- 28 Apr 2015 (actual)
- Primary completion
- 9 Sep 2015 (actual)
- Study completion
- 9 Sep 2015 (actual)
- First posted
- 11 Mar 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 simeprevir (SMV) following single dose administration of age-appropriate oral formulation candidates compared to the 150 milligram (mg) capsule, and to assess the effect of food on the bioavailability of SMV following single dose administration of a selected age-appropriate oral formulation candidate.
Detailed description
This is a Phase 1, open-label (all people know the identity of the intervention), randomized (study medication assigned to participants by chance), 2-panel, 3-way crossover (participants will receive different interventions sequentially during the trial) study in healthy adult participants. Participants will be equally divided over 2 panels, and will not be randomized between panels. Participants will not be allowed to switch panels. The study consists of 3 parts: Screening Phase (that is, 28 days before study commences on Day 1); Open-label Treatment (in subsequent 3-treatment periods in each Panel, each separated with washout period of 7 days); and Post-Treatment Phase (up to 7 days after last study drug intake). The duration of the study per participant will be at least 19 days, screening and follow-up not included. All the eligible participants will be randomly assigned to 1 of the 6 treatment sequences in each Panel. In fasted conditions, study drug will be administered following a 10-hour overnight fast. In fed conditions, participants will also fast from food for 10 hours, but will consume a high fat/high calorie breakfast within a 30-minute period. Study drug will be administered 30 minutes after the start of breakfast. Participants will not be allowed to have food until at least 4 hours after study drug administration. Blood samples will be collected for evaluation of pharmacokinetics at pre-dose and post-dose of study treatment. Relative bioavailability of SMV formulations will be evaluated primarily. Participants' safety will be monitored throughout the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 12
| Arm | Type | Receives |
|---|---|---|
| Panel1: Sequence 1 (ABC) | Experimental | Drug: Treatment A, Drug: Treatment B, Drug: Treatment CParticipants 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. |
| Panel1: Sequence 2 (BCA) | Experimental | Drug: Treatment A, Drug: Treatment B, Drug: Treatment CParticipants 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. |
| Panel1: Sequence 3 (CAB) | Experimental | Drug: Treatment A, Drug: Treatment B, Drug: Treatment CParticipants 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. |
| Panel1: Sequence 4 (CBA) | Experimental | Drug: Treatment A, Drug: Treatment B, Drug: Treatment CParticipants 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. |
| Panel1: Sequence 5 (BAC) | Experimental | Drug: Treatment A, Drug: Treatment B, Drug: Treatment CParticipants 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. |
| Panel1: Sequence 6 (ACB) | Experimental | Drug: Treatment A, Drug: Treatment B, Drug: Treatment CParticipants 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. |
| Panel 2: Sequence 1 (DEF) | Experimental | Drug: Treatment D, Drug: Treatment E, Drug: Treatment FParticipants 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. |
| Panel 2: Sequence 2 (EFD) | Experimental | Drug: Treatment D, Drug: Treatment E, Drug: Treatment FParticipants 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. |
| Panel 2: Sequence 3 (FDE) | Experimental | Drug: Treatment D, Drug: Treatment E, Drug: Treatment FParticipants 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. |
| Panel 2: Sequence 4 (FED) | Experimental | Drug: Treatment D, Drug: Treatment E, Drug: Treatment FParticipants 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. |
| Panel 2: Sequence 5 (EDF) | Experimental | Drug: Treatment D, Drug: Treatment E, Drug: Treatment FParticipants 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. |
| Panel 2: Sequence 6 (DFE) | Experimental | Drug: Treatment D, Drug: Treatment E, Drug: Treatment FParticipants 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. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Participants must be healthy on the basis of physical examination, medical history, 12-lead electrocardiogram (ECG) and vital signs performed at screening (after signing the ICF), and on Day -1 of the first treatment session, if applicable. If there are abnormalities, the participant may be included only if the Investigator judges the abnormalities or deviations from normal to be not clinically significant. This determination must be recorded in the participant's source documents
- 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
Key exclusion criteria (5 listed)
- Female participants who are pregnant or breast feeding at screening or on Day -1 of the first treatment session
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Treatment AAlso: simeprevir150 milligram (mg) SMV capsule with water under fed conditions. | Drug | Panel1: Sequence 1 (ABC), Panel1: Sequence 2 (BCA), Panel1: Sequence 3 (CAB), Panel1: Sequence 4 (CBA), Panel1: Sequence 5 (BAC), Panel1: Sequence 6 (ACB) |
| Treatment BAlso: simeprevirTreatment B (3*50 mg capsules of SMV (including 50 mini-tablets of 1 mg each) with water under fed conditions. | Drug | Panel1: Sequence 1 (ABC), Panel1: Sequence 2 (BCA), Panel1: Sequence 3 (CAB), Panel1: Sequence 4 (CBA), Panel1: Sequence 5 (BAC), Panel1: Sequence 6 (ACB) |
| Treatment CAlso: simeprevirTreatment C (3*50 mg dispersible SMV tablets dispersed in water under fed conditions). | Drug | Panel1: Sequence 1 (ABC), Panel1: Sequence 2 (BCA), Panel1: Sequence 3 (CAB), Panel1: Sequence 4 (CBA), Panel1: Sequence 5 (BAC), Panel1: Sequence 6 (ACB) |
| Treatment DAlso: simeprevir*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. | Drug | Panel 2: Sequence 1 (DEF), Panel 2: Sequence 2 (EFD), Panel 2: Sequence 3 (FDE), Panel 2: Sequence 4 (FED), Panel 2: Sequence 5 (EDF), Panel 2: Sequence 6 (DFE) |
| Treatment EAlso: simeprevir3*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. | Drug | Panel 2: Sequence 1 (DEF), Panel 2: Sequence 2 (EFD), Panel 2: Sequence 3 (FDE), Panel 2: Sequence 4 (FED), Panel 2: Sequence 5 (EDF), Panel 2: Sequence 6 (DFE) |
| Treatment FAlso: simeprevir3*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. | Drug | Panel 2: Sequence 1 (DEF), Panel 2: Sequence 2 (EFD), Panel 2: Sequence 3 (FDE), Panel 2: Sequence 4 (FED), Panel 2: Sequence 5 (EDF), Panel 2: Sequence 6 (DFE) |
Primary outcome
Maximum Plasma Concentration (Cmax) of Simeprevir (SMV)
Time frame: Baseline up to 72 hours post-administration of study drug
The Cmax is the maximum observed plasma concentration of SMV.
Time to Reach the Maximum Plasma Concentration (Tmax) of SMV
Time frame: Baseline up to 72 hours post-administration of study drug
The Tmax is the time to reach the maximum observed plasma concentration of SMV.
Area Under the Plasma Concentration-Time Curve From 0 to last (AUC[0-last]) Post Dose of SMV
Time frame: Baseline up to 72 hours post-administration of study drug
AUC (0-last) from time 0 to the time of the last measurable (non-below quantification limit [BQL]) concentration, calculated by linear-linear trapezoidal summation.
Area Under the Plasma Concentration-Time Curve From 0 to Infinite Time (AUC[0-infinity]) Post Dose of SMV
Time frame: Baseline up to 72 hours post-administration of study drug
The AUC (0-infinity) is the area under the plasma concentration-time curve from time 0 to infinite time, calculated as the sum of AUC (0-last) and C(last)/lambda(z), in which AUC(0-last) is area under the plasma concentration-time curve from time zero to time of the last quantifiable concentration, C(last) is the last observed quantifiable concentration and lambda(z) is elimination rate constant.
Elimination Rate Constant (Lambda [z]) of SMV
Time frame: Baseline up to 72 hours post-administration of study drug
The Lambda (z) determined by linear regression of the terminal points of the ln-linear plasma concentration-time curve.
Terminal Half-life (t[1/2]) of SMV
Time frame: Baseline up to 72 hours post-administration of study drug
The t(1/2) is defined as 0.693/Lambda (z).
2 secondary outcomes
Number of Participants within Each Category of Taste Questionnaire
Time frame: 5 to 15 minutes post administration of study drug (up to Day 19)
Number of Participants with Adverse Events (AEs) and Serious AEs
Time frame: Screening up to follow-up (7 days after last dose administration)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Sep 2017.
Related trials for Healthy
Recruiting
THE EFFECTS OF GAME-BASED EXERCISE PROGRAMS
Physical Activity, Body Image
Not yet recruitingPhase 1
A Phase I Study of GLR2053 Tablets in Chinese Healthy Adult Participants
Atopic Dermatitis
Recruiting
Colon-delivered Riboflavin and Gut Microbiota Composition
Microbiome Dysbiosis, Gut Health
Not yet recruiting
Neuroergonomic Analysis of a Brain-Computer Interface Device (BCI)
Healthy Volunteers - Male and Female
RecruitingPhase 1
First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
Healthy Volunteer, Atopic Dermatitis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Janssen Sciences Ireland UC Clinical Trial study director
Janssen Sciences Ireland UC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Treatment A, Treatment B and Treatment C in people with Healthy, run by Janssen Sciences Ireland UC at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Sep 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximum Plasma Concentration (Cmax) of Simeprevir (SMV) (time frame: Baseline up to 72 hours post-administration of study drug). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Sep 2017.