HealthyPhase 1NCT02426632
Study to Evaluate Taste Profile of Different JNJ-53718678 Oral Liquid Formulations in Healthy Participants
A Phase 1 study testing Formulation A, Formulation B and Formulation C in people with Healthy, run by Janssen Sciences Ireland UC at 1 site in United Kingdom.
Trial summary
The primary objective is to evaluate in a double-blinded (neither physician nor participant knows the treatment that the participant receives), fashion the taste of different JNJ-53718678 oral liquid formulations as compared to the reference formulation (JNJ-53718678, 10 milligram/milliliter oral solution without… Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Formulation A, Formulation B and Formulation C
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 4 Mar 2015to 24 Apr 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Female participants of childbearing potential should have a urine pregnancy test at screening which should be negative
- Participants must be non-smokers and/or have not used chewing tobacco for at least one month prior to screening
- Participants must be willing/able to adhere to the prohibitions and restrictions specified in the protocol and study procedures
- Participants must be able to taste and smell normally, to their own opinion, at all times throughout the study duration. Participants who have an impaired sense of taste and/or smell due to any conditions like common cold or sinusitis are not eligible to take part or to continue to study
- Participants must agree to use an adequate method of contraception
Who cannot join
- Participant has a mouth pathology including, but not limited to, pain, ulcer, edema, mucosal erosion, and/or (dental) abscesses, or receives treatment for oral pathologies or oral treatment for any disease
- Participant has a history of any illness that, in the opinion of the Investigator, might confound the results of the study or pose an additional risk in administering study drug to the participant or that could prevent, limit or confound the protocol specified assessments. This may include but is not limited to renal dysfunction, significant cardiac, vascular, pulmonary, gastrointestinal (such as significant diarrhea, gastric stasis, or constipation that in the Investigator's opinion could influence drug absorption or bioavailability), endocrine, neurologic, hematologic, rheumatologic, psychiatric, neoplastic, or metabolic disturbances
- Participants with a history of clinically significant allergies, hypersensitivity, or intolerance to drugs such as, but not limited to, sulfonamides and penicillins, drug allergy witnessed in previous studies with experimental drugs, or to JNJ-53718678 or its excipients
- Participants with a history or evidence of use of alcohol, barbiturates, amphetamines, recreational or narcotic drug use within the past 3 months, which in the Investigator's opinion would compromise participant's safety and/or compliance with the study procedures
- Participants having received an investigational drug (including investigational vaccines) or used an invasive investigational device within 3 months before the planned first dose of study drugs or is currently enrolled in an investigational study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1, Double-blind, Randomized, Trial to Evaluate the Taste Profile of Different JNJ-53718678 Oral Liquid Formulations in Healthy Subjects
The primary objective is to evaluate in a double-blinded (neither physician nor participant knows the treatment that the participant receives), fashion the taste of different JNJ-53718678 oral liquid formulations as compared to the reference formulation (JNJ-53718678, 10 milligram/milliliter oral solution without sweetener/flavor).
Read the detailed description
This is a Phase 1, double-blind, randomized (participants taste the same groups of drugs [formulations] but in random order), single-center trial in healthy adult participants. The study will include 2 Sessions of 1 day, 1) Session 1, in which participants will receive 6 JNJ-53718678 oral solutions (1 reference and 5 different formulations) sequentially in a randomized order, Scoring of the taste will be done via a questionnaire designed for this purpose; 2) Session 2, within approximately a timeframe of 7 to 14 days after completion of Session 1, participants will taste 2 best scoring tastes coming out of Session 1. The study will consist of a screening phase of approximately 2 weeks, treatment phase of approximately 2 weeks and a post-treatment follow-up phase of 10 days after completion of the last Session. The total study duration for each participant will be approximately 6 weeks.
- Conditions
- Healthy
- Being tested
- Formulation A, Formulation B, Formulation C, Formulation D, Formulation E
- Keywords
- Healthy, JNJ-53718678
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Formulation ADrug
Also called JNJ-53718678
Reference formulation, 10 milligram/milliliter (mg/mL)oral solution without sweetener/flavor.
Formulation BDrug
Also called JNJ-53718678
10 mg/mL oral solution containing 2 mg/mL sucralose, masking flavor and orange flavor.
Formulation CDrug
Also called JNJ-53718678
10 mg/mL oral solution containing 10 mg/mL sucralose.
Formulation DDrug
Also called JNJ-53718678
10 mg/mL oral solution containing 2 mg/mL sucralose and raspberry flavor.
Formulation EDrug
Also called JNJ-53718678
10 mg/mL oral solution containing 2 mg/mL sucralose and strawberry flavor.
Formulation FDrug
Also called JNJ-53718678
10 mg/mL oral solution containing 2 mg/mL sucralose and orange flavor.
Formulation M1Drug
Also called JNJ-53718678
Best scoring formulation from Session 1 with a varying concentration of sucralose (maximum 10 mg/mL).
Formulation M2Drug
Also called JNJ-53718678
Best scoring formulation from Session 1 with a varying concentration of sucralose (maximum 10 mg/mL).
Formulation M3Drug
Also called JNJ-53718678
Best scoring formulation from Session 1 with a varying concentration of sucralose (maximum 10 mg/mL).
Formulation N1Drug
Also called JNJ-53718678
Second best scoring formulation from Session 1 with a varying concentration of sucralose (maximum 10 mg/mL).
Formulation N2Drug
Also called JNJ-53718678
Second best scoring formulation from Session 1 with a varying concentration of sucralose (maximum 10 mg/mL).
Formulation N3Drug
Also called JNJ-53718678
Second best scoring formulation from Session 1 with a varying concentration of sucralose (maximum 10 mg/mL).
| Study group | Role | What they receive |
|---|---|---|
| Session 1: Sequence 1 | Experimental | Participants will sequentially receive 5 milliliter of each 6 JNJ-53718678 formulations (ABCDEF) in a random order, at a dosing interval of 1-2 hours. Receives: Drug: Formulation A; Drug: Formulation B; Drug: Formulation C; Drug: Formulation D; Drug: Formulation E; Drug: Formulation F |
| Session 1: Sequence 2 | Experimental | Participants will sequentially receive 5 milliliter of each 6 JNJ-53718678 formulations (ABCDEF) in a random order, at a dosing interval of 1-2 hours. Receives: Drug: Formulation A; Drug: Formulation B; Drug: Formulation C; Drug: Formulation D; Drug: Formulation E; Drug: Formulation F |
| Session 1: Sequence 3 | Experimental | Participants will sequentially receive 5 milliliter of each 6 JNJ-53718678 formulations (ABCDEF) in a random order, at a dosing interval of 1-2 hours. Receives: Drug: Formulation A; Drug: Formulation B; Drug: Formulation C; Drug: Formulation D; Drug: Formulation E; Drug: Formulation F |
| Session 1: Sequence 4 | Experimental | Participants will sequentially receive 5 milliliter of each 6 JNJ-53718678 formulations (ABCDEF) in a random order, at a dosing interval of 1-2 hours. Receives: Drug: Formulation A; Drug: Formulation B; Drug: Formulation C; Drug: Formulation D; Drug: Formulation E; Drug: Formulation F |
| Session 1: Sequence 5 | Experimental | Participants will sequentially receive 5 milliliter of each 6 JNJ-53718678 formulations (ABCDEF) in a random order, at a dosing interval of 1-2 hours. Receives: Drug: Formulation A; Drug: Formulation B; Drug: Formulation C; Drug: Formulation D; Drug: Formulation E; Drug: Formulation F |
| Session 1: Sequence 6 | Experimental | Participants will sequentially receive 5 milliliter of each 6 JNJ-53718678 formulations (ABCDEF) in a random order, at a dosing interval of 1-2 hours. Receives: Drug: Formulation A; Drug: Formulation B; Drug: Formulation C; Drug: Formulation D; Drug: Formulation E; Drug: Formulation F |
| Session 2: Sequence 7 | Experimental | Participants will receive two best scoring formulations from Session 1 with a varying concentration of sucralose (M1M2M3N1N2N3) sequentially in a random order, at a dosing interval of 1-2 hours. Receives: Drug: Formulation M1; Drug: Formulation M2; Drug: Formulation M3; Drug: Formulation N1; Drug: Formulation N2; Drug: Formulation N3 |
| Session 2: Sequence 8 | Experimental | Participants will receive two best scoring formulations from Session 1 with a varying concentration of sucralose (M1M2M3N1N2N3) sequentially in a random order, at a dosing interval of 1-2 hours. Receives: Drug: Formulation M1; Drug: Formulation M2; Drug: Formulation M3; Drug: Formulation N1; Drug: Formulation N2; Drug: Formulation N3 |
| Session 2: Sequence 9 | Experimental | Participants will receive two best scoring formulations from Session 1 with a varying concentration of sucralose (M1M2M3N1N2N3) sequentially in a random order, at a dosing interval of 1-2 hours. Receives: Drug: Formulation M1; Drug: Formulation M2; Drug: Formulation M3; Drug: Formulation N1; Drug: Formulation N2; Drug: Formulation N3 |
| Session 2: Sequence 10 | Experimental | Participants will receive two best scoring formulations from Session 1 with a varying concentration of sucralose (M1M2M3N1N2N3) sequentially in a random order, at a dosing interval of 1-2 hours. Receives: Drug: Formulation M1; Drug: Formulation M2; Drug: Formulation M3; Drug: Formulation N1; Drug: Formulation N2; Drug: Formulation N3 |
| Session 2: Sequence 11 | Experimental | Participants will receive two best scoring formulations from Session 1 with a varying concentration of sucralose (M1M2M3N1N2N3) sequentially in a random order, at a dosing interval of 1-2 hours. Receives: Drug: Formulation M1; Drug: Formulation M2; Drug: Formulation M3; Drug: Formulation N1; Drug: Formulation N2; Drug: Formulation N3 |
| Session 2: Sequence 12 | Experimental | Participants will receive two best scoring formulations from Session 1 with a varying concentration of sucralose (M1M2M3N1N2N3) sequentially in a random order, at a dosing interval of 1-2 hours. Receives: Drug: Formulation M1; Drug: Formulation M2; Drug: Formulation M3; Drug: Formulation N1; Drug: Formulation N2; Drug: Formulation N3 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acceptability Score
Formulations will be assessed using Acceptability Questionnaire, which evaluates sweetness, bitterness, aroma type, aroma strength, smell and overall acceptability using visual analogue scales (VAS) with range from 0 (super bad) to 100 (super good).
Measured: up to 12 hour post-administration of study drug
Secondary outcomes (1)
Number of Participants with Local and Systemic adverse Events
Measured: Screening up to end of Study (Week 6)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2015 (estimated)
- Study start4 Mar 2015
- Primary completion24 Apr 2015
- Study completion24 Apr 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
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 12 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
- NCT02426632
- Sponsor's protocol ID
- CR106726
- Other IDs
- 53718678RSV1003, 2014-005157-39, 2014
- Status last verified
- May 2018
- First submitted
- 22 Apr 2015
- Last updated
- 15 May 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Double-blind, Randomized, Trial to Evaluate the Taste Profile of Different JNJ-53718678 Oral Liquid Formulations in Healthy Subjects
- ClinicalTrials.gov ID
- NCT02426632
- Acronym / sponsor ID
- CR106726
- Conditions
- Healthy
- Keywords
- Healthy, JNJ-53718678
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Janssen Sciences Ireland UCIndustry (pharma, biotech, devices)
- Study start
- 4 Mar 2015 (actual)
- Primary completion
- 24 Apr 2015 (actual)
- Study completion
- 24 Apr 2015 (actual)
- First posted
- 27 Apr 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 primary objective is to evaluate in a double-blinded (neither physician nor participant knows the treatment that the participant receives), fashion the taste of different JNJ-53718678 oral liquid formulations as compared to the reference formulation (JNJ-53718678, 10 milligram/milliliter oral solution without sweetener/flavor).
Detailed description
This is a Phase 1, double-blind, randomized (participants taste the same groups of drugs [formulations] but in random order), single-center trial in healthy adult participants. The study will include 2 Sessions of 1 day, 1) Session 1, in which participants will receive 6 JNJ-53718678 oral solutions (1 reference and 5 different formulations) sequentially in a randomized order, Scoring of the taste will be done via a questionnaire designed for this purpose; 2) Session 2, within approximately a timeframe of 7 to 14 days after completion of Session 1, participants will taste 2 best scoring tastes coming out of Session 1. The study will consist of a screening phase of approximately 2 weeks, treatment phase of approximately 2 weeks and a post-treatment follow-up phase of 10 days after completion of the last Session. The total study duration for each participant will be approximately 6 weeks.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 12
| Arm | Type | Receives |
|---|---|---|
| Session 1: Sequence 1 | Experimental | Drug: Formulation A, Drug: Formulation B, Drug: Formulation C, Drug: Formulation D, Drug: Formulation E, Drug: Formulation FParticipants will sequentially receive 5 milliliter of each 6 JNJ-53718678 formulations (ABCDEF) in a random order, at a dosing interval of 1-2 hours. |
| Session 1: Sequence 2 | Experimental | Drug: Formulation A, Drug: Formulation B, Drug: Formulation C, Drug: Formulation D, Drug: Formulation E, Drug: Formulation FParticipants will sequentially receive 5 milliliter of each 6 JNJ-53718678 formulations (ABCDEF) in a random order, at a dosing interval of 1-2 hours. |
| Session 1: Sequence 3 | Experimental | Drug: Formulation A, Drug: Formulation B, Drug: Formulation C, Drug: Formulation D, Drug: Formulation E, Drug: Formulation FParticipants will sequentially receive 5 milliliter of each 6 JNJ-53718678 formulations (ABCDEF) in a random order, at a dosing interval of 1-2 hours. |
| Session 1: Sequence 4 | Experimental | Drug: Formulation A, Drug: Formulation B, Drug: Formulation C, Drug: Formulation D, Drug: Formulation E, Drug: Formulation FParticipants will sequentially receive 5 milliliter of each 6 JNJ-53718678 formulations (ABCDEF) in a random order, at a dosing interval of 1-2 hours. |
| Session 1: Sequence 5 | Experimental | Drug: Formulation A, Drug: Formulation B, Drug: Formulation C, Drug: Formulation D, Drug: Formulation E, Drug: Formulation FParticipants will sequentially receive 5 milliliter of each 6 JNJ-53718678 formulations (ABCDEF) in a random order, at a dosing interval of 1-2 hours. |
| Session 1: Sequence 6 | Experimental | Drug: Formulation A, Drug: Formulation B, Drug: Formulation C, Drug: Formulation D, Drug: Formulation E, Drug: Formulation FParticipants will sequentially receive 5 milliliter of each 6 JNJ-53718678 formulations (ABCDEF) in a random order, at a dosing interval of 1-2 hours. |
| Session 2: Sequence 7 | Experimental | Drug: Formulation M1, Drug: Formulation M2, Drug: Formulation M3, Drug: Formulation N1, Drug: Formulation N2, Drug: Formulation N3Participants will receive two best scoring formulations from Session 1 with a varying concentration of sucralose (M1M2M3N1N2N3) sequentially in a random order, at a dosing interval of 1-2 hours. |
| Session 2: Sequence 8 | Experimental | Drug: Formulation M1, Drug: Formulation M2, Drug: Formulation M3, Drug: Formulation N1, Drug: Formulation N2, Drug: Formulation N3Participants will receive two best scoring formulations from Session 1 with a varying concentration of sucralose (M1M2M3N1N2N3) sequentially in a random order, at a dosing interval of 1-2 hours. |
| Session 2: Sequence 9 | Experimental | Drug: Formulation M1, Drug: Formulation M2, Drug: Formulation M3, Drug: Formulation N1, Drug: Formulation N2, Drug: Formulation N3Participants will receive two best scoring formulations from Session 1 with a varying concentration of sucralose (M1M2M3N1N2N3) sequentially in a random order, at a dosing interval of 1-2 hours. |
| Session 2: Sequence 10 | Experimental | Drug: Formulation M1, Drug: Formulation M2, Drug: Formulation M3, Drug: Formulation N1, Drug: Formulation N2, Drug: Formulation N3Participants will receive two best scoring formulations from Session 1 with a varying concentration of sucralose (M1M2M3N1N2N3) sequentially in a random order, at a dosing interval of 1-2 hours. |
| Session 2: Sequence 11 | Experimental | Drug: Formulation M1, Drug: Formulation M2, Drug: Formulation M3, Drug: Formulation N1, Drug: Formulation N2, Drug: Formulation N3Participants will receive two best scoring formulations from Session 1 with a varying concentration of sucralose (M1M2M3N1N2N3) sequentially in a random order, at a dosing interval of 1-2 hours. |
| Session 2: Sequence 12 | Experimental | Drug: Formulation M1, Drug: Formulation M2, Drug: Formulation M3, Drug: Formulation N1, Drug: Formulation N2, Drug: Formulation N3Participants will receive two best scoring formulations from Session 1 with a varying concentration of sucralose (M1M2M3N1N2N3) sequentially in a random order, at a dosing interval of 1-2 hours. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Female participants of childbearing potential should have a urine pregnancy test at screening which should be negative
- Participants must be non-smokers and/or have not used chewing tobacco for at least one month prior to screening
- Participants must be willing/able to adhere to the prohibitions and restrictions specified in the protocol and study procedures
- Participants must be able to taste and smell normally, to their own opinion, at all times throughout the study duration. Participants who have an impaired sense of taste and/or smell due to any conditions like common cold or sinusitis are not eligible to take part or to continue to study
- Participants must agree to use an adequate method of contraception
Key exclusion criteria (5 listed)
- Participant has a mouth pathology including, but not limited to, pain, ulcer, edema, mucosal erosion, and/or (dental) abscesses, or receives treatment for oral pathologies or oral treatment for any disease
- Participant has a history of any illness that, in the opinion of the Investigator, might confound the results of the study or pose an additional risk in administering study drug to the participant or that could prevent, limit or confound the protocol specified assessments. This may include but is not limited to renal dysfunction, significant cardiac, vascular, pulmonary, gastrointestinal (such as significant diarrhea, gastric stasis, or constipation that in the Investigator's opinion could influence drug absorption or bioavailability), endocrine, neurologic, hematologic, rheumatologic, psychiatric, neoplastic, or metabolic disturbances
- Participants with a history of clinically significant allergies, hypersensitivity, or intolerance to drugs such as, but not limited to, sulfonamides and penicillins, drug allergy witnessed in previous studies with experimental drugs, or to JNJ-53718678 or its excipients
- Participants with a history or evidence of use of alcohol, barbiturates, amphetamines, recreational or narcotic drug use within the past 3 months, which in the Investigator's opinion would compromise participant's safety and/or compliance with the study procedures
- Participants having received an investigational drug (including investigational vaccines) or used an invasive investigational device within 3 months before the planned first dose of study drugs or is currently enrolled in an investigational study
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 |
|---|---|---|
| Formulation AAlso: JNJ-53718678Reference formulation, 10 milligram/milliliter (mg/mL)oral solution without sweetener/flavor. | Drug | Session 1: Sequence 1, Session 1: Sequence 2, Session 1: Sequence 3, Session 1: Sequence 4, Session 1: Sequence 5, Session 1: Sequence 6 |
| Formulation BAlso: JNJ-5371867810 mg/mL oral solution containing 2 mg/mL sucralose, masking flavor and orange flavor. | Drug | Session 1: Sequence 1, Session 1: Sequence 2, Session 1: Sequence 3, Session 1: Sequence 4, Session 1: Sequence 5, Session 1: Sequence 6 |
| Formulation CAlso: JNJ-5371867810 mg/mL oral solution containing 10 mg/mL sucralose. | Drug | Session 1: Sequence 1, Session 1: Sequence 2, Session 1: Sequence 3, Session 1: Sequence 4, Session 1: Sequence 5, Session 1: Sequence 6 |
| Formulation DAlso: JNJ-5371867810 mg/mL oral solution containing 2 mg/mL sucralose and raspberry flavor. | Drug | Session 1: Sequence 1, Session 1: Sequence 2, Session 1: Sequence 3, Session 1: Sequence 4, Session 1: Sequence 5, Session 1: Sequence 6 |
| Formulation EAlso: JNJ-5371867810 mg/mL oral solution containing 2 mg/mL sucralose and strawberry flavor. | Drug | Session 1: Sequence 1, Session 1: Sequence 2, Session 1: Sequence 3, Session 1: Sequence 4, Session 1: Sequence 5, Session 1: Sequence 6 |
| Formulation FAlso: JNJ-5371867810 mg/mL oral solution containing 2 mg/mL sucralose and orange flavor. | Drug | Session 1: Sequence 1, Session 1: Sequence 2, Session 1: Sequence 3, Session 1: Sequence 4, Session 1: Sequence 5, Session 1: Sequence 6 |
| Formulation M1Also: JNJ-53718678Best scoring formulation from Session 1 with a varying concentration of sucralose (maximum 10 mg/mL). | Drug | Session 2: Sequence 10, Session 2: Sequence 11, Session 2: Sequence 12, Session 2: Sequence 7, Session 2: Sequence 8, Session 2: Sequence 9 |
| Formulation M2Also: JNJ-53718678Best scoring formulation from Session 1 with a varying concentration of sucralose (maximum 10 mg/mL). | Drug | Session 2: Sequence 10, Session 2: Sequence 11, Session 2: Sequence 12, Session 2: Sequence 7, Session 2: Sequence 8, Session 2: Sequence 9 |
| Formulation M3Also: JNJ-53718678Best scoring formulation from Session 1 with a varying concentration of sucralose (maximum 10 mg/mL). | Drug | Session 2: Sequence 10, Session 2: Sequence 11, Session 2: Sequence 12, Session 2: Sequence 7, Session 2: Sequence 8, Session 2: Sequence 9 |
| Formulation N1Also: JNJ-53718678Second best scoring formulation from Session 1 with a varying concentration of sucralose (maximum 10 mg/mL). | Drug | Session 2: Sequence 10, Session 2: Sequence 11, Session 2: Sequence 12, Session 2: Sequence 7, Session 2: Sequence 8, Session 2: Sequence 9 |
| Formulation N2Also: JNJ-53718678Second best scoring formulation from Session 1 with a varying concentration of sucralose (maximum 10 mg/mL). | Drug | Session 2: Sequence 10, Session 2: Sequence 11, Session 2: Sequence 12, Session 2: Sequence 7, Session 2: Sequence 8, Session 2: Sequence 9 |
| Formulation N3Also: JNJ-53718678Second best scoring formulation from Session 1 with a varying concentration of sucralose (maximum 10 mg/mL). | Drug | Session 2: Sequence 10, Session 2: Sequence 11, Session 2: Sequence 12, Session 2: Sequence 7, Session 2: Sequence 8, Session 2: Sequence 9 |
Primary outcome
Acceptability Score
Time frame: up to 12 hour post-administration of study drug
Formulations will be assessed using Acceptability Questionnaire, which evaluates sweetness, bitterness, aroma type, aroma strength, smell and overall acceptability using visual analogue scales (VAS) with range from 0 (super bad) to 100 (super good).
1 secondary outcome
Number of Participants with Local and Systemic adverse Events
Time frame: Screening up to end of Study (Week 6)
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 15 May 2018.
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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 Formulation A, Formulation B and Formulation 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 15 May 2018. 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?
Acceptability Score (time frame: up to 12 hour post-administration of study drug). 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 15 May 2018.