AzTrials
AzTrials

HealthyPhase 1NCT02813460

Study to Assess the Taste Profile of Different ALS-008176 Oral Liquid Formulations in Healthy Adult Participants

A Phase 1 study testing Formulation A (ALS-008176), Formulation B (ALS-008176) and Formulation C (ALS-008176) in people with Healthy, run by Janssen Research & Development, LLC at 1 site in United Kingdom.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

The purpose of this study is to evaluate in a double-blinded fashion the taste and overall acceptability profile of different ALS-008176 oral liquid formulations as compared to the reference formulation (ALS-008176: 60 milligram per milliliters (mg/mL) oral suspension without sweetener/flavor) for pediatric clinical… 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 (ALS-008176), Formulation B (ALS-008176) and Formulation C (ALS-008176)
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
11 participants
Where
1 siteUnited Kingdom
Study dates
Jun 2016to Aug 2016
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

  • Participant must be a man or woman between 18 and 65 years of age, inclusive, at Screening
  • Participant must sign an informed consent form (ICF) indicating that he or she understands the purpose of, and procedures required for, the study and is willing to participate in the study
  • Participant must be willing and able to adhere to the prohibitions and restrictions specified in this protocol
  • A female participant must be of non-childbearing potential, defined as either: 1) Postmenopausal; 2) A postmenopausal state is defined as no menses for at least 12 months without an alternative medical cause and a serum follicle stimulating hormone (FSH) level in the postmenopausal range (more than [>] 40 international units per liter [IU/L] or milli international units per milliliters [mIU/mL]), or 3) Permanently sterile; 4) Permanent sterilization methods include hysterectomy, bilateral salpingectomy, bilateral tubal occlusion/ligation procedures (without reversal operation), and bilateral oophorectomy
  • During the study and for a minimum of one spermatogenesis cycle (defined as approximately 90 days) after receiving the (last dose of) study drug, a male participant 1) who is sexually active with a woman of childbearing potential must agree to use a barrier method of contraception (example, condom with spermicidal foam/gel/film/cream/suppository); 2) who is sexually active with a pregnant woman must use a condom; 3) must agree not to donate sperm
  • Female partners of male participants must either be surgically sterilized, postmenopausal or, if of childbearing potential, must agree to use at least one of the following contraceptive methods for 90 days following the final dose of study drug: a nonhormonal intrauterine device with spermicide; contraceptive sponge with spermicide, diaphragm with spermicide, cervical cap with spermicide, or oral, implantable, transdermal, or injectable-hormonal contraceptives
Show all 12Show fewer
  • A female participant must have a negative serum beta human chorionic gonadotropin (beta hCG) pregnancy test at Screening and a negative urine pregnancy test at Day 1 predose
  • A female participant must agree not to donate eggs during the study and for at least 90 days after receiving the (last dose of) study drug
  • Participant must have a body mass index; weight (kilogram per height square [kg/height^2 [m^2]) between 18.0 and 30.0 kilogram per meter square (kg/m^2)(inclusive) at Screening
  • Participant must be non-smokers and/or have not used chewing tobacco for at least 3 months prior to Screening
  • Participant 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 such as allergic rhinitis, common cold or sinusitis are not eligible to take part in or to continue the study
  • Participant must be able to read and write

Who cannot join

  • Participant has a mouth pathology including, but not limited to, pain, ulcer, edema, mucosal erosion, gingivitis and/or (dental) abscesses, or receives treatment for oral pathologies or oral treatment for any disease
  • Participant has a history of current clinically significant medical illness including Sjogren's syndrome, cardiac arrhythmias or other cardiac disease, pernicious anemia, hematologic disease, coagulation disorders, lipid abnormalities, significant pulmonary disease, including bronchospastic respiratory disease, diabetes mellitus, hepatic or renal insufficiency, thyroid disease, neurologic or psychiatric disease, infection, or any other illness that the Investigator considers should exclude the participant or that could interfere with the interpretation of the study results
  • Participant with a history of clinically significant drug allergy such as, but not limited to, sulfonamides and penicillins, or drug allergy diagnosed in previous studies with experimental drugs
  • Participant with presence of any febrile illness or symptoms of upper or lower respiratory tract infection in the 14 days before the (first) dose of study drugs
  • Participant has a history of drug or alcohol abuse according to Diagnostic and Statistical Manual of Mental Disorders (5th edition) (DSM-V) criteria within 5 years before screening or positive test result(s) for alcohol and/or drugs of abuse (including barbiturates, opiates, cocaine, amphetamines, methadone, benzodiazepines, methamphetamine, tetrahydrocannabinol, phencyclidine, and tricyclic antidepressants) at Screening
  • Participant has known allergies, hypersensitivity, or intolerance to ALS-008176 or its excipients
Show all 11Show fewer
  • Participant has received an investigational drug (including investigational vaccines) or used an invasive investigational medical device within 90 days before the planned first dose of study drug
  • Participant is a man who plans to father a child while enrolled in this study or within 90 days after the last dose of study drug, or who is unwilling to use acceptable methods of contraception
  • Vulnerable participant (example, incarcerated individuals)
  • Participant is an employee of the Investigator or study site, with direct involvement in the proposed study or other studies under the direction of that Investigator or study site, as well as family members of the employees or the Investigator or participant is an employee of Johnson \& Johnson
  • Participant has any condition for which, in the opinion of the Investigator, participation would not be in the best interest of the participant (example, compromise the well-being) or that could prevent, limit, or confound the protocol-specified assessments

Trial locations and contacts

1 site in 1 country.

United Kingdom1 site

  • Study site

    Nottingham

Other trials in United Kingdom

About this study

Official title: A Phase 1, Double-blind, Randomized Study to Assess the Taste Profile of Different ALS-008176 Oral Liquid Formulations in Healthy Adult Subjects

The purpose of this study is to evaluate in a double-blinded fashion the taste and overall acceptability profile of different ALS-008176 oral liquid formulations as compared to the reference formulation (ALS-008176: 60 milligram per milliliters (mg/mL) oral suspension without sweetener/flavor) for pediatric clinical development and commercialization.

Conditions
Healthy
Being tested
Formulation A (ALS-008176), Formulation B (ALS-008176), Formulation C (ALS-008176), Formulation D (ALS-008176), Formulation E (ALS-008176)

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Formulation A (ALS-008176)Drug

    Reference formulation, 60 mg/mL ALS-008176 oral suspension without sweetener/flavor.

  • Formulation B (ALS-008176)Drug

    60 mg/mL ALS-008176 oral suspension containing 12 mg/mL sucralose.

  • Formulation C (ALS-008176)Drug

    60 mg/mL ALS-008176 oral suspension containing 4 mg/mL sucralose and strawberry flavor.

  • Formulation D (ALS-008176)Drug

    60 mg/mL ALS-008176 oral suspension containing 4 mg/mL sucralose and masking flavor and strawberry flavor.

  • Formulation E (ALS-008176)Drug

    60 mg/mL ALS-008176 oral suspension containing 4 mg/mL sucralose and masking flavor and cream vanille flavor.

  • Formulation F (ALS-008176)Drug

    60 mg/mL ALS-008176 oral suspension containing 4 mg/mL sucralose and fantasy fruit flavor.

  • Formulation G1 (ALS-008176)Drug

    60 mg/mL ALS-008176 oral suspension with concentration 1 of sucralose (maximum 12 mg/mL) and best flavor 1 from session 1.

  • Formulation G2 (ALS-008176)Drug

    60 mg/mL ALS-008176 oral suspension with concentration 2 of sucralose (maximum 12 mg/mL) and best flavor 1 from session 1.

  • Formulation G3 (ALS-008176)Drug

    60 mg/mL ALS-008176 oral suspension with concentration 3 of sucralose (maximum 12 mg/mL) and best flavor 1 from session 1.

  • Formulation H1 (ALS-008176)Drug

    60 mg/mL ALS-008176 oral suspension with concentration 1 of sucralose (maximum 12 mg/mL) and best flavor 2 from session 1.

  • Formulation H2 (ALS-008176)Drug

    60 mg/mL ALS-008176 oral suspension with concentration 2 of sucralose (maximum 12 mg/mL) and best flavor 2 from session 1.

  • Formulation H3 (ALS-008176)Drug

    60 mg/mL ALS-008176 oral suspension with concentration 3 of sucralose (maximum 12 mg/mL) and best flavor 2 from session 1.

Study groups in NCT02813460
Study groupRoleWhat they receive
Session 1: Sequence 1ExperimentalParticipants will sequentially receive 5 milliliters (mL) of each 6 ALS-008176 formulations A B F C E D on day 1.
Receives: Drug: Formulation A (ALS-008176); Drug: Formulation B (ALS-008176); Drug: Formulation C (ALS-008176); Drug: Formulation D (ALS-008176); Drug: Formulation E (ALS-008176); Drug: Formulation F (ALS-008176)
Session 1: Sequence 2ExperimentalParticipants will sequentially receive 5 mL of each 6 ALS-008176 formulations B C A D F E on day 1.
Receives: Drug: Formulation A (ALS-008176); Drug: Formulation B (ALS-008176); Drug: Formulation C (ALS-008176); Drug: Formulation D (ALS-008176); Drug: Formulation E (ALS-008176); Drug: Formulation F (ALS-008176)
Session 1: Sequence 3ExperimentalParticipants will sequentially receive 5 mL of each 6 ALS-008176 formulations C D B E A F on day 1.
Receives: Drug: Formulation A (ALS-008176); Drug: Formulation B (ALS-008176); Drug: Formulation C (ALS-008176); Drug: Formulation D (ALS-008176); Drug: Formulation E (ALS-008176); Drug: Formulation F (ALS-008176)
Session 1: Sequence 4ExperimentalParticipants will sequentially receive 5 mL of each 6 ALS-008176 formulations D E C F B A on day 1.
Receives: Drug: Formulation A (ALS-008176); Drug: Formulation B (ALS-008176); Drug: Formulation C (ALS-008176); Drug: Formulation D (ALS-008176); Drug: Formulation E (ALS-008176); Drug: Formulation F (ALS-008176)
Session 1: Sequence 5ExperimentalParticipants will sequentially receive 5 mL of each 6 ALS-008176 formulations E F D A C B on day 1.
Receives: Drug: Formulation A (ALS-008176); Drug: Formulation B (ALS-008176); Drug: Formulation C (ALS-008176); Drug: Formulation D (ALS-008176); Drug: Formulation E (ALS-008176); Drug: Formulation F (ALS-008176)
Session 1: Sequence 6ExperimentalParticipants will sequentially receive 5 mL of each 6 ALS-008176 formulations F A E B D C on day 1.
Receives: Drug: Formulation A (ALS-008176); Drug: Formulation B (ALS-008176); Drug: Formulation C (ALS-008176); Drug: Formulation D (ALS-008176); Drug: Formulation E (ALS-008176); Drug: Formulation F (ALS-008176)
Session 2: Sequence 1ExperimentalParticipants will receive 5 mL of two best scoring formulations from Session 1 with 3 varying concentrations of sucralose (G1 G2 H3 G3 H2 H1).
Receives: Drug: Formulation G1 (ALS-008176); Drug: Formulation G2 (ALS-008176); Drug: Formulation G3 (ALS-008176); Drug: Formulation H1 (ALS-008176); Drug: Formulation H2 (ALS-008176); Drug: Formulation H3 (ALS-008176)
Session 2: Sequence 2ExperimentalParticipants will receive 5 mL of two best scoring formulations from Session 1 with 3 varying concentrations of sucralose (G2 G3 G1 H1 H3 H2).
Receives: Drug: Formulation G1 (ALS-008176); Drug: Formulation G2 (ALS-008176); Drug: Formulation G3 (ALS-008176); Drug: Formulation H1 (ALS-008176); Drug: Formulation H2 (ALS-008176); Drug: Formulation H3 (ALS-008176)
Session 2: Sequence 3ExperimentalParticipants will receive 5 mL of two best scoring formulations from Session 1 with 3 varying concentrations of sucralose (G3 H1 G2 H2 G1 H3).
Receives: Drug: Formulation G1 (ALS-008176); Drug: Formulation G2 (ALS-008176); Drug: Formulation G3 (ALS-008176); Drug: Formulation H1 (ALS-008176); Drug: Formulation H2 (ALS-008176); Drug: Formulation H3 (ALS-008176)
Session 2: Sequence 4ExperimentalParticipants will receive 5 mL of two best scoring formulations from Session 1 with 3 varying concentrations of sucralose (H1 H2 G3 H3 G2 G1).
Receives: Drug: Formulation G1 (ALS-008176); Drug: Formulation G2 (ALS-008176); Drug: Formulation G3 (ALS-008176); Drug: Formulation H1 (ALS-008176); Drug: Formulation H2 (ALS-008176); Drug: Formulation H3 (ALS-008176)
Session 2: Sequence 5ExperimentalParticipants will receive 5 mL of two best scoring formulations from Session 1 with 3 varying concentrations of sucralose (H2 H3 H1 G1 G3 G2).
Receives: Drug: Formulation G1 (ALS-008176); Drug: Formulation G2 (ALS-008176); Drug: Formulation G3 (ALS-008176); Drug: Formulation H1 (ALS-008176); Drug: Formulation H2 (ALS-008176); Drug: Formulation H3 (ALS-008176)
Session 2: Sequence 6ExperimentalParticipants will receive 5 mL of two best scoring formulations from Session 1 with 3 varying concentrations of sucralose (H3 G1 H2 G2 H1 G3).
Receives: Drug: Formulation G1 (ALS-008176); Drug: Formulation G2 (ALS-008176); Drug: Formulation G3 (ALS-008176); Drug: Formulation H1 (ALS-008176); Drug: Formulation H2 (ALS-008176); Drug: Formulation H3 (ALS-008176)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Evaluate in a Double-Blinded Fashion the Taste and Overall Acceptability Profile of Different ALS-008176 Oral Liquid Formulations as Compared to the Reference Formulation (ALS-008176: 60 mg/mL Oral Suspension Without Sweetener/Flavor)

    Taste will be assessed using a questionnaire designed for the purpose. The questionnaire will consist of a visual analogue scale to rate 5 items (sweetness, bitterness, aroma type, aroma strength, and smell) as well as overall acceptability.

    Measured: Up to 2 hours of study drug administration

Secondary outcomes (1)

  1. Number of participants with adverse events and serious adverse events as a measure of safety and tolerability

    Measured: Up to 6 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Jun 2016 (estimated)
  2. Study startJun 2016
  3. Primary completionAug 2016
  4. Study completionAug 2016

Resources

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
Double blind
Who is masked
Participant, Investigator
Enrolment
11 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02813460
Sponsor's protocol ID
CR108168
Other IDs
64041575RSV1004, 2016-001517-24, 2016
Status last verified
Jan 2025
First submitted
2 Jun 2016
Last updated
3 Feb 2025
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Formulation A (ALS-008176), Formulation B (ALS-008176) and Formulation C (ALS-008176) in people with Healthy, run by Janssen Research & Development, LLC 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 12 inclusion and 11 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 3 Feb 2025. 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?

Evaluate in a Double-Blinded Fashion the Taste and Overall Acceptability Profile of Different ALS-008176 Oral Liquid Formulations as Compared to the Reference Formulation (ALS-008176: 60 mg/mL Oral Suspension Without Sweetener/Flavor) (time frame: Up to 2 hours of study drug administration). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02813460.

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 3 Feb 2025.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in