Respiratory Syncytial Virus InfectionsPhase 1NCT02478333

A Study to Investigate the Safety, Tolerability, and Pharmacokinetics of ALS-008176 in Healthy Japanese Adult Participants

A Phase 1 study testing ALS-008176 (250 mg), ALS-008176 (500 mg) and ALS-008176 (750 mg) in people with Respiratory Syncytial Virus Infections, run by Janssen Pharmaceutical K.K. at 1 site in Japan.

Completed

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

Official record

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Trial summary

The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics of ALS-008176 following oral administration of single ascending dose of ALS-008176 in healthy Japanese adult participants. Read more about this study

Who is it for?: Ages 20 to 55 yearsHealthy volunteers can take part
Conditions the study is for: Respiratory Syncytial Virus Infections
What is being tested?: ALS-008176 (250 mg), ALS-008176 (500 mg) and ALS-008176 (750 mg)
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 24 participants
Where: 1 siteJapan
Study dates: May 2015to Jul 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 20 to 55 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

Be a Japanese participant whose parents and grandparents are Japanese as determined by the participant's verbal report
Each participant must sign an Informed Consent Form (ICF) indicating that he or she understands the purpose of and procedures required for the study and are 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 either:
Not of childbearing potential: postmenopausal [greater than (>) 45 years of age with amenorrhea for at least 2 years, or any age with amenorrhea for at least 6 months and a serum follicle stimulating hormone (FSH) level >40 International Units (IU)/ liter (L) (to be confirmed at Screening for all postmonopausal women)] OR
Permanently sterilized (eg, bilateral tubal occlusion [which includes tubal ligation procedures as consistent with local regulations], hysterectomy, bilateral salpingectomy, bilateral oophorectomy) or otherwise incapable of becoming pregnant, OR c. If of childbearing potential and heterosexually active, practicing an effective method of birth control before entry and agree to continue to use two effective methods of contraception throughout the study and for at least 30 days after receiving the study drug
Participant must be a non-smoker for at least one month prior to screening

Who cannot join

Participant has a history of current clinically significant medical illness including (but not limited to) cardiac arrhythmias or other cardiac disease, hematologic disease, coagulation disorders (including any abnormal bleeding or blood dyscrasias), 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 past history of heart arrhythmias (extrasystoli, tachycardia at rest), history of risk factors for Torsade de Pointes syndrome (eg, hypokalemia, family history of long QT Syndrome)
Participant has creatinine clearance of lower than 70 millilitre (mL)/min
Participant has taken any disallowed therapies as noted in protocol, Pre-study and Concomitant Therapy before the planned study drug
Participant has a history of human immunodeficiency virus (HIV) antibody positive, or tests positive for HIV at screening

Trial locations and contacts

1 site in 1 country.

Japan1 site

Study site
Fukuoka

Other trials in Japan

About this study

Official title: A Double-Blind, Placebo-Controlled, Randomized, Single Ascending Dose Study to Investigate Safety, Tolerability, and Pharmacokinetics of ALS-008176 in Healthy Japanese Adult Subjects

Read the detailed description

This is a double-blind (test or experiment in which neither the person giving the treatment nor the patient knows which treatment the patient is receiving), placebo-controlled, randomized (study medication assigned to participants by chance) and single-center study of ALS-008176. The duration of study will be approximately 6 weeks for each participant. The study consists of 3 parts: Screening Phase (28 days before study commences on Day 1); double-blind Treatment Phase (single oral dose of ALS-008176 or placebo on Day 1 under fasted condition); and Follow up Phase (up to 14 days after study drug administration). All the eligible participants will be randomly assigned to receive either a single oral dose of ALS-008176 or placebo in each group. The planned doses will be escalated in a stepwise fashion if the safety and tolerability in the preceding dose is found acceptable. Participants in Group 1 will receive ALS-008176, 250 milligram (mg) or placebo, Group 2 will receive ALS-008176, 500 mg or placebo and Group 3 will receive ALS-008176, 750 mg or placebo. Study drug will be administered following a 10-hour overnight fast. Blood samples will be collected for evaluation of pharmacokinetics at pre-dose and post-dose of study treatment. Pharmacokinetics of ALS-008176, ALS-008206, ALS-008112, and its metabolite ALS 008144 will be evaluated primarily. Participants' safety will be monitored throughout the study.

Conditions: Respiratory Syncytial Virus Infections
Being tested: ALS-008176 (250 mg), ALS-008176 (500 mg), ALS-008176 (750 mg), Placebo
Keywords: Healthy, ALS-008176, Japanese adult participants
Medical subject headings: Respiratory Syncytial Virus Infections

What participants receive

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

ALS-008176 (250 mg)Drug
Participants will receive ALS-008176, 250 mg oral suspension once on Day 1 under fasted conditions.
ALS-008176 (500 mg)Drug
Participants will receive ALS-008176, 500 mg oral suspension once on Day 1 under fasted conditions.
ALS-008176 (750 mg)Drug
Participants will receive ALS-008176, 750 mg oral suspension once on Day 1 under fasted conditions.
PlaceboOther
Participants will receive placebo oral suspension once on Day 1 under fasted conditions.

Study groups in NCT02478333
Study group	Role	What they receive
ALS-008176 (250 mg) or Placebo	Experimental	Participants will receive ALS-008176, 250 milligram (mg) or placebo oral suspension once on Day 1 under fasted conditions. Receives: Drug: ALS-008176 (250 mg); Other: Placebo
ALS-008176 (500 mg) or Placebo	Experimental	Participants will receive ALS-008176, 500 milligram (mg) or placebo oral suspension once on Day 1 under fasted conditions. Receives: Drug: ALS-008176 (500 mg); Other: Placebo
ALS-008176 (750 mg) or Placebo	Experimental	Participants will receive ALS-008176, 750 milligram (mg) or placebo oral suspension once on Day 1 under fasted conditions. Receives: Drug: ALS-008176 (750 mg); Other: Placebo

What is being measured

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

Maximum Plasma Concentration (Cmax) of ALS 008176, ALS-008206, ALS-008112, and ALS-008144
The Cmax is the maximum observed plasma concentration of ALS 008176, ALS-008206, ALS-008112, and ALS-008144.
Measured: Pre-dose; 0.25, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72, 96, 120 and 144 hours post-dose
Time to Reach the Maximum Plasma Concentration (Tmax) of ALS 008176, ALS-008206, ALS-008112, and ALS-008144
The Tmax is the time to reach the maximum observed plasma concentration of ALS 008176, ALS-008206, ALS-008112, and ALS-008144.
Measured: Pre-dose; 0.25, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72, 96, 120 and 144 hours post-dose
Time of Last Measurable Plasma Concentration (Tlast) of ALS 008176, ALS-008206, ALS-008112, and ALS-008144
Time of last measurable (non-below quantification limit [non-BQL]) plasma concentration.
Measured: Pre-dose; 0.25, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72, 96, 120 and 144 hours post-dose
Area Under the Plasma Concentration-Time Curve From Time 0 to Time of the Last Observed Quantifiable Concentration (AUC [0-last]) of ALS 008176, ALS-008206, ALS-008112, and ALS-008144
The AUC (0-last) is the area under the plasma ALS 008176, ALS-008206, ALS-008112, and ALS-008144 concentration-time curve from time 0 to time of the last observed (non-BQL) quantifiable concentration, calculated by linear-linear trapezoidal summation.
Measured: Pre-dose; 0.25, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72, 96, 120 and 144 hours post-dose
Area Under the Plasma Concentration-Time Curve From 0 to Infinite Time (AUC[0-infinity]) Post Dose of ALS 008176, ALS-008206, ALS-008112, and ALS-008144
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 ALS 008176, ALS-008206, ALS-008112, and ALS-008144 concentration-time curve from time zero to time of the last quantifiable concentration, C(last) is the last observed (non-BQL) quantifiable concentration and lambda(z) is elimination rate constant. Extrapolations of more than 20.00% of the total AUC are reported as approximations.
Measured: Pre-dose; 0.25, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72, 96, 120 and 144 hours post-dose
Percentage of Area Under the Plasma Concentration-Time Curve Obtained by Extrapolation (%AUC[infinity,ex])
The %AUC[infinity,ex] is calculated by dividing the difference of AUC(0-infinity) and AUC(0-last) by AUC(0-infinity) and then multiplying by 100, (AUC[0-infinity] - AUC[0-last])*100/AUC[0-infinity].
Measured: Pre-dose; 0.25, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72, 96, 120 and 144 hours post-dose
Apparent Initial Elimination Rate Constant (Lambda [alpha]) of ALS 008176, ALS-008206, ALS-008112, and ALS-008144
The Lambda (alpha) determined by linear regression of the first elimination phase of the ln-linear plasma concentration-time curve.
Measured: Pre-dose; 0.25, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72, 96, 120 and 144 hours post-dose
Apparent Terminal Elimination Rate Constant (Lambda [z]) of ALS 008176, ALS-008206, ALS-008112, and ALS-008144
The Lambda (z) determined by linear regression of the terminal points of the ln-linear plasma concentration-time curve.
Measured: Pre-dose; 0.25, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72, 96, 120 and 144 hours post-dose
Apparent Initial Half-life (t[1/2alpha]) of ALS 008176, ALS-008206, ALS-008112, and ALS-008144
The t(1/2alpha) is defined as 0.693/Lambda (alpha).
Measured: Pre-dose; 0.25, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72, 96, 120 and 144 hours post-dose
Apparent Terminal Half-life (t[1/2term]) of ALS 008176, ALS-008206, ALS-008112, and ALS-008144
The t(1/2term) is defined as 0.693/Lambda (z).
Measured: Pre-dose; 0.25, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72, 96, 120 and 144 hours post-dose
Amount of ALS 008176, ALS-008206, ALS-008112, and ALS-008144 excreted in Urine (Ae[x-y])
Amount excreted into urine over a given time interval, calculated from the urinary drug concentration of the collection interval x to y hours post dosing multiplied with the associated urine volume of the interval.
Measured: Up to 48 hours post-dose
Total Amount of ALS 008176, ALS-008206, ALS-008112, and ALS-008144 excreted in Urine (Ae[total])
Total amount excreted into urine, calculated by adding the amounts of the individual intervals together {Ae[0-48hours(h)]}.
Measured: Up to 48 hours post-dose
Total Percentage of ALS 008176, ALS-008206, ALS-008112, and ALS-008144 dose excreted into urine
Total percentage of the dose excreted into urine, calculated as 100 * (Ae[total]/Dose).
Measured: Up to 48 hours post-dose
Renal clearance
Renal clearance calculated as Ae (0-48h)/AUC (0-48h).
Measured: Up to 48 hours post-dose

Secondary outcomes (1)

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 (14 days after dose administration)

Timeline

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

May 2015Jul 2015

First posted23 Jun 2015 (estimated)
Study startMay 2015
Primary completionJul 2015
Study completionJul 2015

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Respiratory Syncytial Virus InfectionsStudies 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
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 24 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02478333
Sponsor's protocol ID: CR107180
Other IDs: 64041575RSV1001
Status last verified: Jul 2016
First submitted: 18 Jun 2015
Last updated: 11 Jul 2016
Results posted: No
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 11 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Double-Blind, Placebo-Controlled, Randomized, Single Ascending Dose Study to Investigate Safety, Tolerability, and Pharmacokinetics of ALS-008176 in Healthy Japanese Adult Subjects
ClinicalTrials.gov ID: NCT02478333
Acronym / sponsor ID: CR107180
Conditions: Respiratory Syncytial Virus Infections
Keywords: Healthy, ALS-008176, Japanese adult participants
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 24 participants (actual)
Lead sponsor: Janssen Pharmaceutical K.K.Industry (pharma, biotech, devices)
Study start: May 2015
Primary completion: Jul 2015 (actual)
Study completion: Jul 2015 (actual)
First posted: 23 Jun 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.

Detailed description

Study design

Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 3

Arm	Type	Receives
ALS-008176 (250 mg) or Placebo	Experimental	Drug: ALS-008176 (250 mg), Other: PlaceboParticipants will receive ALS-008176, 250 milligram (mg) or placebo oral suspension once on Day 1 under fasted conditions.
ALS-008176 (500 mg) or Placebo	Experimental	Drug: ALS-008176 (500 mg), Other: PlaceboParticipants will receive ALS-008176, 500 milligram (mg) or placebo oral suspension once on Day 1 under fasted conditions.
ALS-008176 (750 mg) or Placebo	Experimental	Drug: ALS-008176 (750 mg), Other: PlaceboParticipants will receive ALS-008176, 750 milligram (mg) or placebo oral suspension once on Day 1 under fasted conditions.

Who may qualify

Ages: 20 to 55 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (7 listed)

Be a Japanese participant whose parents and grandparents are Japanese as determined by the participant's verbal report
Each participant must sign an Informed Consent Form (ICF) indicating that he or she understands the purpose of and procedures required for the study and are 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 either:
Participant must be a non-smoker for at least one month prior to screening

Key exclusion criteria (5 listed)

Participant has a history of current clinically significant medical illness including (but not limited to) cardiac arrhythmias or other cardiac disease, hematologic disease, coagulation disorders (including any abnormal bleeding or blood dyscrasias), 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 past history of heart arrhythmias (extrasystoli, tachycardia at rest), history of risk factors for Torsade de Pointes syndrome (eg, hypokalemia, family history of long QT Syndrome)
Participant has creatinine clearance of lower than 70 millilitre (mL)/min
Participant has taken any disallowed therapies as noted in protocol, Pre-study and Concomitant Therapy before the planned study drug
Participant has a history of human immunodeficiency virus (HIV) antibody positive, or tests positive for HIV at screening

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
ALS-008176 (250 mg)Participants will receive ALS-008176, 250 mg oral suspension once on Day 1 under fasted conditions.	Drug	ALS-008176 (250 mg) or Placebo
ALS-008176 (500 mg)Participants will receive ALS-008176, 500 mg oral suspension once on Day 1 under fasted conditions.	Drug	ALS-008176 (500 mg) or Placebo
ALS-008176 (750 mg)Participants will receive ALS-008176, 750 mg oral suspension once on Day 1 under fasted conditions.	Drug	ALS-008176 (750 mg) or Placebo
PlaceboParticipants will receive placebo oral suspension once on Day 1 under fasted conditions.	Other	ALS-008176 (250 mg) or Placebo, ALS-008176 (500 mg) or Placebo, ALS-008176 (750 mg) or Placebo

Primary outcome

Maximum Plasma Concentration (Cmax) of ALS 008176, ALS-008206, ALS-008112, and ALS-008144
Time frame: Pre-dose; 0.25, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72, 96, 120 and 144 hours post-dose
The Cmax is the maximum observed plasma concentration of ALS 008176, ALS-008206, ALS-008112, and ALS-008144.
Time to Reach the Maximum Plasma Concentration (Tmax) of ALS 008176, ALS-008206, ALS-008112, and ALS-008144
Time frame: Pre-dose; 0.25, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72, 96, 120 and 144 hours post-dose
The Tmax is the time to reach the maximum observed plasma concentration of ALS 008176, ALS-008206, ALS-008112, and ALS-008144.
Time of Last Measurable Plasma Concentration (Tlast) of ALS 008176, ALS-008206, ALS-008112, and ALS-008144
Time frame: Pre-dose; 0.25, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72, 96, 120 and 144 hours post-dose
Time of last measurable (non-below quantification limit [non-BQL]) plasma concentration.
Area Under the Plasma Concentration-Time Curve From Time 0 to Time of the Last Observed Quantifiable Concentration (AUC [0-last]) of ALS 008176, ALS-008206, ALS-008112, and ALS-008144
Time frame: Pre-dose; 0.25, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72, 96, 120 and 144 hours post-dose
The AUC (0-last) is the area under the plasma ALS 008176, ALS-008206, ALS-008112, and ALS-008144 concentration-time curve from time 0 to time of the last observed (non-BQL) quantifiable 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 ALS 008176, ALS-008206, ALS-008112, and ALS-008144
Time frame: Pre-dose; 0.25, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72, 96, 120 and 144 hours post-dose
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 ALS 008176, ALS-008206, ALS-008112, and ALS-008144 concentration-time curve from time zero to time of the last quantifiable concentration, C(last) is the last observed (non-BQL) quantifiable concentration and lambda(z) is elimination rate constant. Extrapolations of more than 20.00% of the total AUC are reported as approximations.
Percentage of Area Under the Plasma Concentration-Time Curve Obtained by Extrapolation (%AUC[infinity,ex])
Time frame: Pre-dose; 0.25, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72, 96, 120 and 144 hours post-dose
The %AUC[infinity,ex] is calculated by dividing the difference of AUC(0-infinity) and AUC(0-last) by AUC(0-infinity) and then multiplying by 100, (AUC[0-infinity] - AUC[0-last])*100/AUC[0-infinity].
Apparent Initial Elimination Rate Constant (Lambda [alpha]) of ALS 008176, ALS-008206, ALS-008112, and ALS-008144
Time frame: Pre-dose; 0.25, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72, 96, 120 and 144 hours post-dose
The Lambda (alpha) determined by linear regression of the first elimination phase of the ln-linear plasma concentration-time curve.
Apparent Terminal Elimination Rate Constant (Lambda [z]) of ALS 008176, ALS-008206, ALS-008112, and ALS-008144
Time frame: Pre-dose; 0.25, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72, 96, 120 and 144 hours post-dose
The Lambda (z) determined by linear regression of the terminal points of the ln-linear plasma concentration-time curve.
Apparent Initial Half-life (t[1/2alpha]) of ALS 008176, ALS-008206, ALS-008112, and ALS-008144
Time frame: Pre-dose; 0.25, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72, 96, 120 and 144 hours post-dose
The t(1/2alpha) is defined as 0.693/Lambda (alpha).
Apparent Terminal Half-life (t[1/2term]) of ALS 008176, ALS-008206, ALS-008112, and ALS-008144
Time frame: Pre-dose; 0.25, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72, 96, 120 and 144 hours post-dose
The t(1/2term) is defined as 0.693/Lambda (z).
Amount of ALS 008176, ALS-008206, ALS-008112, and ALS-008144 excreted in Urine (Ae[x-y])
Time frame: Up to 48 hours post-dose
Amount excreted into urine over a given time interval, calculated from the urinary drug concentration of the collection interval x to y hours post dosing multiplied with the associated urine volume of the interval.
Total Amount of ALS 008176, ALS-008206, ALS-008112, and ALS-008144 excreted in Urine (Ae[total])
Time frame: Up to 48 hours post-dose
Total amount excreted into urine, calculated by adding the amounts of the individual intervals together {Ae[0-48hours(h)]}.
Total Percentage of ALS 008176, ALS-008206, ALS-008112, and ALS-008144 dose excreted into urine
Time frame: Up to 48 hours post-dose
Total percentage of the dose excreted into urine, calculated as 100 * (Ae[total]/Dose).
Renal clearance
Time frame: Up to 48 hours post-dose
Renal clearance calculated as Ae (0-48h)/AUC (0-48h).

1 secondary outcome

Number of Participants with Adverse Events (AEs) and Serious AEs
Time frame: Screening up to follow-up (14 days after 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 11 Jul 2016.

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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 Pharmaceutical K.K., Japan Clinical Trial study director

Janssen Pharmaceutical K.K.

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 ALS-008176 (250 mg), ALS-008176 (500 mg) and ALS-008176 (750 mg) in people with Respiratory Syncytial Virus Infections, run by Janssen Pharmaceutical K.K. at 1 site in Japan.

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 7 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 11 Jul 2016. 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 Japan. 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 ALS 008176, ALS-008206, ALS-008112, and ALS-008144 (time frame: Pre-dose; 0.25, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72, 96, 120 and 144 hours post-dose). The study lists 14 primary outcomes in all. 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 NCT02478333.

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 11 Jul 2016.