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

• Register: ClinicalTrials.gov
• Last refreshed on: 21 July 2016
• Main ID: NCT02478333
• Date of registration: 18/06/2015
• Prospective Registration: No
• Primary sponsor: Janssen Pharmaceutical K.K.
• Public title: A Study to Investigate the Safety, Tolerability, and Pharmacokinetics of ALS-008176 in Healthy Japanese Adult Participants
• Scientific 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
• Date of first enrolment: May 2015
• Target sample size: 24
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02478333
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator)
• Phase: Phase 1

Countries of recruitment

Japan

Contacts

• Name: Janssen Pharmaceutical K.K., Japan Clinical Trial
• Affiliation: Janssen Pharmaceutical K.K.

Key inclusion & exclusion criteria

Inclusion Criteria:

- 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:

1. 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

2. 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

Exclusion Criteria:

- 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



Age minimum: 20 Years
Age maximum: 55 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Respiratory Syncytial Virus Infections

Intervention(s)

Drug: ALS-008176 (750 mg)

Drug: ALS-008176 (250 mg)

Drug: ALS-008176 (500 mg)

Other: Placebo

Primary Outcome(s)

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]

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]

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]

Renal clearance [Time Frame: Up to 48 hours post-dose]

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]

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]

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]

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]

Total Percentage of ALS 008176, ALS-008206, ALS-008112, and ALS-008144 dose excreted into urine [Time Frame: Up to 48 hours post-dose]

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]

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]

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]

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]

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]

Secondary Outcome(s)

Number of Participants with Adverse Events (AEs) and Serious AEs [Time Frame: Screening up to follow-up (14 days after dose administration)]

Secondary ID(s)

CR107180

64041575RSV1001

Source(s) of Monetary Support

Please refer to primary and secondary sponsors