Clinical trial NCT02824315: Study to Investigate the Pharmacokinetic Interaction Between 2 Direct Acting Antiviral Agents Odalasvir and AL-335 and Between 3 Direct Acting Antiviral Agents Simeprevir, Odalasvir and AL-335 at Steady State in Healthy Japanese Participants
Official title: A Phase 1, Open-label, Fixed Sequence Study to Investigate the Pharmacokinetic Interaction Between 2 Direct Acting Antiviral Agents Odalasvir and AL-335 and Between 3 Direct Acting Antiviral Agents Simeprevir, Odalasvir and AL-335 at Steady State 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: 2016-07-06
Enrollment: 22
Sex: ALL
Minimum age (years): 20
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to investigate the steady-state pharmacokinetics (PK) of simeprevir (SMV), odalasvir (ODV) and AL-335 (and its metabolites ALS-022399 and ALS 022227), when these drugs are co-administered in healthy Japanese participants.


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 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 is supine for 5 minutes) between 90 and 140 milligram 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 after last 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 with a past history of heart arrhythmias (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 \[example- sibling, offspring, or biological parent\])
* 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 simeprevir (SMV), odalasvir (ODV), AL-335 or their excipients
* Participant is a woman who is pregnant, or breast-feeding, or planning to become pregnant from signing of Informed Consent Form (ICF) until 60 days after last study drug administration or until the last follow-up visit, whichever occurs later

Primary outcomes:
measure: Average Analyte Concentration at Steady State (Cavg,ss)
timeFrame: Up to Day 36
measure: Maximum Observed Analyte Concentration (Cmax)
timeFrame: Up to Day 36
measure: Minimum Observed Analyte Concentration (Cmin)
timeFrame: Up to Day 36
measure: Trough Plasma Concentration (Ctrough)
timeFrame: Up to Day 36
measure: Time to Reach Maximum Observed Analyte Concentration (Tmax)
timeFrame: Up to Day 36
measure: Area Under the Analyte Concentration-Time Curve From Time 0 to 24 Hours (AUC24)
timeFrame: Up to Day 36
measure: Fluctuation Index (FI)
timeFrame: Up to Day 36
measure: Area Under the Analyte Concentration-Time Curve From Time Zero to Time of the Last Quantifiable Concentration (AUClast)
timeFrame: Up to Day 36
measure: Area Under the Analyte Concentration-Time Curve From Time Zero to Infinite Time (AUC [0-infinity])
timeFrame: Up to Day 36
measure: Elimination Rate Constant (Lambda[z])
timeFrame: Up to Day 36
measure: Elimination Half-Life (t1/2)
timeFrame: Up to Day 36
Secondary outcomes:
measure: Number of Participants With Adverse Events (AE) as a Measure of Safety and Tolerability
timeFrame: Up to Follow-up (170 to 175 days after last study drug intake)
Other outcomes:
Locations:
city: Surrey
country: United Kingdom
Study officials:
affiliation: Janssen Research & Development, LLC
name: Janssen Research & Development, LLC Clinical Trial
role: STUDY_DIRECTOR
References: