Clinical trial NCT02821858: Study to Investigate the Pharmacokinetics, Safety and Tolerability of Odalasvir and AL-335 in Healthy Japanese Participants
Official title: A Phase 1, Double-blind, Placebo-controlled, Randomized, Single Ascending Dose Study to Investigate the Pharmacokinetics, Safety and Tolerability of Odalasvir and AL-335 in Healthy Japanese Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Janssen Research & Development, LLC
Sponsor class: INDUSTRY
First posted: 2016-07-04
Enrollment: 40
Sex: ALL
Minimum age (years): 20
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to investigate the pharmacokinetics (PK), safety and tolerability following single oral administration of ascending doses of odalasvir (ODV) in healthy Japanese participants (Panel 1) and to investigate the PK, safety and tolerability following single oral administration of ascending doses of AL-335 in healthy Japanese participants (Panel 2; Sequential Design).


Eligibility criteria: Inclusion Criteria:

* Participant must be a Japanese participant who has resided outside Japan for no more than 5 years and whose parents and grandparents are Japanese as determined by participant's verbal report
* Participant must have a body mass index (BMI: weight in kilogram \[kg\] divided by the square of height in meters) of 18.0 to 30.0 kilogram per meter square (kg/m\^2), extremes included and a body weight not less than 50.0 kilogram (kg)
* Participant must be healthy on the basis of physical examination, medical history, vital signs, and 12-lead electrocardiogram (ECG) performed at Screening. 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 and initialed by the Investigator
* Participant must have a blood pressure (after the participant supine for 5 minutes) between 90 and 140 millimeter of mercury (mmHg) systolic, inclusive, and no higher than 90 mmHg diastolic. If blood pressure is out of range, up to 2 repeated assessments are permitted
* Female participant must agree to not donate eggs (ova, oocytes) for the purpose of assisted reproduction during the study and for a period of 60 days (Panel 1) or 30 days (Panel 2) after study drug administration or until the last follow-up visit, whichever occurs later

Exclusion Criteria:

* Participant has a history of liver or renal insufficiency (estimated creatinine clearance below 80 milliliters per minute \[mL/min\]); 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
* Participant has any condition for which, in the opinion of the Investigator, participation would not be in the best interest of the participant (for example, compromise the well-being) or that could prevent, limit, or confound the protocol-specified assessments
* Participant with a past history of heart arrhythmias (for example, extra systolic beats or tachycardia at rest); risk factors associated with Torsade de Pointes such as hypokalemia or family history of short/long QT syndrome or sudden unexplained death (including sudden infant death syndrome) in a first-degree relative \[for example, sibling, offspring, or biological parent\])
* Participant with any history of clinically significant skin disease such as, but not limited to, dermatitis, eczema, drug rash, psoriasis, food allergy, or urticaria
* Participant has known allergies, hypersensitivity, or intolerance to odalasvir (ODV) or AL-335 or its excipients

Primary outcomes:
measure: Maximum Observed Concentration (Cmax) of Odalasvir (ODV)
timeFrame: From Day 1 to Day 14 after intake of ODV
measure: Time to Reach Maximum Observed Concentration (Tmax) of ODV
timeFrame: From Day 1 to Day 14 after intake of ODV
measure: Area Under the Concentration-Time Curve From Time Zero to Time of the Last Quantifiable Concentration (AUClast) of ODV
timeFrame: From Day 1 to Day 50-55 after intake of ODV
measure: Elimination Rate Constant (Lambda[z]) of ODV
timeFrame: From Day 1 to Day 50-55 after intake of ODV
measure: Elimination Half-Life (t1/2) of ODV
timeFrame: From Day 1 to Day 50-55 after intake of ODV
measure: Area Under the Concentration-Time Curve From Time Zero to Infinite Time (AUC [0-infinity]) of ODV
timeFrame: From Day 1 to Day 50-55 after intake of ODV
measure: Number of Participants With Adverse Events (AE) as a Measure of Safety and Tolerability for ODV
timeFrame: Up to 50-55 days after intake of ODV
measure: Maximum Observed Concentration (Cmax) of AL-335
timeFrame: From Day 1 to Day 4 after intake of AL-335
measure: Time to Reach Maximum Observed Concentration (Tmax) of AL-335
timeFrame: From Day 1 to Day 4 after intake of AL-335
measure: Area Under the Concentration-Time Curve From Time Zero to Time of the Last Quantifiable Concentration (AUClast) of AL-335
timeFrame: From Day 1 to Day 4 after intake of AL-335
measure: Elimination Rate Constant (Lambda[z]) of AL-335
timeFrame: From Day 1 to Day 4 after intake of AL-335
measure: Elimination Half-Life (t1/2) of AL-335
timeFrame: From Day 1 to Day 4 after intake of AL-335
measure: Area Under the Concentration-Time Curve From Time Zero to Infinite Time (AUC [0-infinity]) of AL-335
timeFrame: From Day 1 to Day 4 after intake of AL-335
measure: Number of Participants With Adverse Events (AE) as a Measure of Safety and Tolerability for AL-335
timeFrame: Up to 30 to 35 days after last intake of AL-335
Secondary outcomes:
Other outcomes:
Locations:
city: Surrey
country: United Kingdom
Study officials:
affiliation: Janssen Research and Developement, LLC
name: Janssen Research and Developement, LLC Clinical Trial
role: STUDY_DIRECTOR
References: