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Completed

NCT Number: NCT02821858

Study to Investigate the Pharmacokinetics, Safety and Tolerability of Odalasvir and AL-335 in Healthy Japanese Participants

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).

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Key information

Conditions

Healthy

Age range

20 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Surrey, United Kingdom

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Odalasvir (ODV)

Drug

ODV 50 mg (1 tablet) in Treatment A, 100 mg (2 tablets of 50 mg) in Treatment B and 300 mg (6 tablets of 50 mg) in Treatment C.

AL-335

Drug

AL-335 400 mg (1 tablet) in Treatment D, 800 mg (2 tablets of 400 mg) in Treatment E and 1200 mg (3 tablets of 400 mg) in Treatment F.

Placebo

Drug

Matching placebo will be administered.

Primary outcomes

  1. Maximum Observed Concentration (Cmax) of Odalasvir (ODV)

    Time frame: From Day 1 to Day 14 after intake of ODV

    The Cmax is the maximum observed analyte concentration.

  2. Time to Reach Maximum Observed Concentration (Tmax) of ODV

    Time frame: From Day 1 to Day 14 after intake of ODV

    The Tmax is defined as actual sampling time to reach maximum observed analyte concentration.

  3. Area Under the Concentration-Time Curve From Time Zero to Time of the Last Quantifiable Concentration (AUClast) of ODV

    Time frame: From Day 1 to Day 50-55 after intake of ODV

    The (AUC [0-last]) is the area under the analyte concentration-time curve from time 0 to time of the last quantifiable concentration.

  4. Elimination Rate Constant (Lambda[z]) of ODV

    Time frame: From Day 1 to Day 50-55 after intake of ODV

    Lambda(z) is first order elimination rate constant associated with the terminal portion of the curve, determined as the negative slope of the terminal log-linear phase of the drug concentration-time curve.

  5. Elimination Half-Life (t1/2) of ODV

    Time frame: From Day 1 to Day 50-55 after intake of ODV

    Elimination half-life (t[1/2]) is associated with the terminal slope (lambda [z]) of the semi-logarithmic drug concentration-time curve, calculated as 0.693/lambda(z).

  6. Area Under the Concentration-Time Curve From Time Zero to Infinite Time (AUC [0-infinity]) of ODV

    Time frame: From Day 1 to Day 50-55 after intake of ODV

    The AUC (0-infinity) is the area under the plasma concentration-time curve from time zero to infinite time, calculated as the sum of AUC(last) and C(last)/lambda(z); wherein AUC(last) is area under the plasma concentration-time curve from time zero to last quantifiable time, C(last) is the last observed quantifiable concentration, and lambda(z) is elimination rate constant.

  7. Number of Participants With Adverse Events (AE) as a Measure of Safety and Tolerability for ODV

    Time frame: Up to 50-55 days after intake of ODV

  8. Maximum Observed Concentration (Cmax) of AL-335

    Time frame: From Day 1 to Day 4 after intake of AL-335

    The Cmax is the maximum observed analyte concentration.

  9. Time to Reach Maximum Observed Concentration (Tmax) of AL-335

    Time frame: From Day 1 to Day 4 after intake of AL-335

    The Tmax is defined as actual sampling time to reach maximum observed concentration.

  10. Area Under the Concentration-Time Curve From Time Zero to Time of the Last Quantifiable Concentration (AUClast) of AL-335

    Time frame: From Day 1 to Day 4 after intake of AL-335

    The (AUC [0-last]) is the area under the concentration-time curve from time 0 to time of the last quantifiable concentration.

  11. Elimination Rate Constant (Lambda[z]) of AL-335

    Time frame: From Day 1 to Day 4 after intake of AL-335

    Lambda(z) is first order elimination rate constant associated with the terminal portion of the curve, determined as the negative slope of the terminal log-linear phase of the drug concentration-time curve.

  12. Elimination Half-Life (t1/2) of AL-335

    Time frame: From Day 1 to Day 4 after intake of AL-335

    Elimination half-life (t[1/2]) is associated with the terminal slope (lambda [z]) of the semi-logarithmic drug concentration-time curve, calculated as 0.693/lambda(z).

  13. Area Under the Concentration-Time Curve From Time Zero to Infinite Time (AUC [0-infinity]) of AL-335

    Time frame: From Day 1 to Day 4 after intake of AL-335

    The AUC (0-infinity) is the area under the plasma concentration-time curve from time zero to infinite time, calculated as the sum of AUC(last) and C(last)/lambda(z); wherein AUC(last) is area under the plasma concentration-time curve from time zero to last quantifiable time, C(last) is the last observed quantifiable concentration, and lambda(z) is elimination rate constant.

  14. Number of Participants With Adverse Events (AE) as a Measure of Safety and Tolerability for AL-335

    Time frame: Up to 30 to 35 days after last intake of AL-335

Sponsors and collaborators

Lead sponsor

Janssen Research & Development, LLC

Industry

Registry information

Official study 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

Important dates

Study start
2016
Primary completion
2016
Study completion
2016
First posted
Jul 4, 2016
Registry last updated
Mar 29, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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