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Completed

NCT Number: NCT02015715

A Study Evaluating the Safety, Pharmacokinetics, and Pharmacodynamics of RO6864018 in Male, Healthy, Asian Participants

This randomized, double-blind, placebo-controlled, single ascending dose study will assess the safety, pharmacokinetics, and pharmacodynamics of RO6864018 in healthy, male, Asian and Caucasian participants. Participants will be enrolled in cohorts and randomized 8:2 to receive a single oral administration of RO6864018 or placebo. Total study duration for each participant is up to 9 weeks.

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Key information

Conditions

Healthy Volunteer

Age range

21 year–65 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Changi General Hospital; Clinical Trial & Research unit, Singapore

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Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Healthy male participants of ethnic Chinese, Korean, Japanese origin or Caucasian
  • No signs of any active or chronic disease following a detailed medical and surgical history, a complete physical examination including vital signs, 12-lead electrocardiogram (ECG), hematology, blood chemistry, serology and urinalysis
  • Body Mass Index (BMI) between 18 to 30 kilograms per square meter (kg/m^2) inclusive, and a weight range of 50 to 100 kilograms (kg) (110 to 220 pounds [lb]) inclusive at screening
  • Non-smokers, or use of less than (<) 10 cigarettes (or equivalent nicotine-containing product) per day

Exclusion criteria

  • History or symptoms of any significant disease
  • Personal or family history of congenital long QT syndrome or sudden death
  • Any confirmed significant allergic reactions against any drug, or multiple drug allergies (non-active hay fever is acceptable)
  • Positive results for anti-nuclear antibody (ANA), anti-mitochondrial antibody (AMA), anti-smooth muscle antibody (ASMA) and thyroid peroxidase antibody
  • Suspicion of regular consumption of drug of abuse
  • History (within 3 months of screening) of alcohol consumption exceeding 14 units per week on average (1 unit = 10 grams of alcohol)
  • Participants who have received Interferon (IFN) or peginterferon within 8 weeks prior to dosing
  • Use of any medication (prescription or over the counter [OTC], including health supplements and herbal remedies) within 2 weeks before the first dose of study medication
  • Positive Hepatitis A immunoglobulin M antibody (HAV IgM Ab), Hepatitis B surface antigen (HBsAg), Hepatitis C antibody (HCV Ab) or human immunodeficiency virus antibody (HIV Ab) at screening
  • Donation or loss of blood of greater than 500 milliliters (mL) within 90 days prior to dosing
  • Have participated in other clinical studies within 60 days prior to study randomization

Treatment and study plan

RO6864018

Drug

A single oral ascending dose of RO6864018 capsules on Day 1.

Placebo

Drug

A single oral dose of placebo matching RO6864018 capsules on Day 1.

Primary outcomes

  1. Number of Participants With Adverse Events

    Time frame: Baseline up to Day 29

Secondary outcomes

  1. Area Under the Plasma Concentration Time Curve From Time Zero to Infinity (AUC0-inf) of RO6864018

    Time frame: Pre-dose (0 hour), 0.25, 0.5, 1, 1.5, 2, 3, 4, 8, 12, 18, 24, 36 and 48 hours post-Day 1 dose

  2. AUC0-inf of Active Metabolite RO6871765

    Time frame: Pre-dose (0 hour), 0.25, 0.5, 1, 1.5, 2, 3, 4, 8, 12, 18, 24, 36 and 48 hours post-Day 1 dose

  3. AUC0-inf of Prodrug Metabolite RO6870868

    Time frame: Pre-dose (0 hour), 0.25, 0.5, 1, 1.5, 2, 3, 4, 8, 12, 18, 24, 36 and 48 hours post-Day 1 dose

  4. AUC0-inf of Minor Metabolite RO6872373

    Time frame: Pre-dose (0 hour), 0.25, 0.5, 1, 1.5, 2, 3, 4, 8, 12, 18, 24, 36 and 48 hours post-Day 1 dose

  5. Area Under the Plasma Concentration Time Curve From Time Zero to Last Measurable Concentration (AUClast) of RO6864018

    Time frame: Pre-dose (0 hour), 0.25, 0.5, 1, 1.5, 2, 3, 4, 8, 12, 18, 24, 36 and 48 hours post-Day 1 dose

  6. AUClast of Active Metabolite RO6871765

    Time frame: Pre-dose (0 hour), 0.25, 0.5, 1, 1.5, 2, 3, 4, 8, 12, 18, 24, 36 and 48 hours post-Day 1 dose

  7. AUClast of Prodrug Metabolite RO6870868

    Time frame: Pre-dose (0 hour), 0.25, 0.5, 1, 1.5, 2, 3, 4, 8, 12, 18, 24, 36 and 48 hours post-Day 1 dose

  8. AUClast of Minor Metabolite RO6872373

    Time frame: Pre-dose (0 hour), 0.25, 0.5, 1, 1.5, 2, 3, 4, 8, 12, 18, 24, 36 and 48 hours post-Day 1 dose

  9. Maximum Observed Plasma Concentration (Cmax) of RO6864018

    Time frame: Pre-dose (0 hour), 0.25, 0.5, 1, 1.5, 2, 3, 4, 8, 12, 18, 24, 36 and 48 hours post-Day 1 dose

  10. Cmax of Active Metabolite RO6871765

    Time frame: Pre-dose (0 hour), 0.25, 0.5, 1, 1.5, 2, 3, 4, 8, 12, 18, 24, 36 and 48 hours post-Day 1 dose

  11. Cmax of Prodrug Metabolite RO6870868

    Time frame: Pre-dose (0 hour), 0.25, 0.5, 1, 1.5, 2, 3, 4, 8, 12, 18, 24, 36 and 48 hours post-Day 1 dose

  12. Cmax of Minor Metabolite RO6872373

    Time frame: Pre-dose (0 hour), 0.25, 0.5, 1, 1.5, 2, 3, 4, 8, 12, 18, 24, 36 and 48 hours post-Day 1 dose

  13. Time to Maximum Plasma Concentration (Tmax) of RO6864018

    Time frame: Pre-dose (0 hour), 0.25, 0.5, 1, 1.5, 2, 3, 4, 8, 12, 18, 24, 36 and 48 hours post-Day 1 dose

  14. Tmax of Active Metabolite RO6871765

    Time frame: Pre-dose (0 hour), 0.25, 0.5, 1, 1.5, 2, 3, 4, 8, 12, 18, 24, 36 and 48 hours post-Day 1 dose

  15. Tmax of Minor Metabolite RO6872373

    Time frame: Pre-dose (0 hour), 0.25, 0.5, 1, 1.5, 2, 3, 4, 8, 12, 18, 24, 36 and 48 hours post-Day 1 dose

  16. RO6864018 Urine Concentration

    Time frame: Pre-dose (0-4 hours before dosing), 0-4, 4-8, 8-12, 12-24, 24-36, and 36-48 hours post-Day 1 dose

  17. Active Metabolite RO6871765 Urine Concentration

    Time frame: Pre-dose (0-4 hours before dosing), 0-4, 4-8, 8-12, 12-24, 24-36, and 36-48 hours post-Day 1 dose

  18. Prodrug Metabolite RO6870868 Urine Concentration

    Time frame: Pre-dose (0-4 hours before dosing), 0-4, 4-8, 8-12, 12-24, 24-36, and 36-48 hours post-Day 1 dose

  19. Minor Metabolite RO6872373 Urine Concentration

    Time frame: Pre-dose (0-4 hours before dosing), 0-4, 4-8, 8-12, 12-24, 24-36, and 36-48 hours post-Day 1 dose

  20. Apparent Terminal Elimination Half-Life (T1/2) of RO6864018

    Time frame: Pre-dose (0 hour), 0.25, 0.5, 1, 1.5, 2, 3, 4, 8, 12, 18, 24, 36 and 48 hours post-Day 1 dose

  21. T1/2 of Active Metabolite RO6871765

    Time frame: Pre-dose (0 hour), 0.25, 0.5, 1, 1.5, 2, 3, 4, 8, 12, 18, 24, 36 and 48 hours post-Day 1 dose

  22. T1/2 of Prodrug Metabolite RO6870868

    Time frame: Pre-dose (0 hour), 0.25, 0.5, 1, 1.5, 2, 3, 4, 8, 12, 18, 24, 36 and 48 hours post-Day 1 dose

  23. T1/2 of Minor Metabolite RO6872373

    Time frame: Pre-dose (0 hour), 0.25, 0.5, 1, 1.5, 2, 3, 4, 8, 12, 18, 24, 36 and 48 hours post-Day 1 dose

  24. Serum Interferon alpha Levels

    Time frame: Pre-dose (0 hours), 3, 6, 12, 18, 24, 36, and 48 hours post-Day 1 dose

  25. Serum Interferon-Gamma-Inducible Protein-10 (IP-10) Levels

    Time frame: Pre-dose (0 hours), 3, 6, 12, 18, 24, 36, and 48 hours post-Day 1 dose

  26. Serum Interleukin (IL)-6 Levels

    Time frame: Pre-dose (0 hours), 3, 6, 12, 18, 24, 36, and 48 hours post-Day 1 dose

  27. Serum IL-10 Levels

    Time frame: Pre-dose (0 hours), 3, 6, 12, 18, 24, 36, and 48 hours post-Day 1 dose

  28. Serum IL-12 Levels

    Time frame: Pre-dose (0 hours), 3, 6, 12, 18, 24, 36, and 48 hours post-Day 1 dose

  29. Serum Neopterin Levels

    Time frame: Pre-dose (0 hours), 3, 6, 12, 18, 24, 36, and 48 hours post-Day 1 dose

  30. Serum p40 (IL-12B) Levels

    Time frame: Pre-dose (0 hours), 3, 6, 12, 18, 24, 36, and 48 hours post-Day 1 dose

  31. Interferon-Stimulated Gene-15 (ISG-15) Messenger Ribonucleic Acid (mRNA) Levels in Whole Blood

    Time frame: Pre-dose (0 hours), 3, 6, 12, 18, 24, 36, and 48 hours post-Day 1 dose

  32. Myxovirus Resistance 1 (MX-1) Gene mRNA Levels in Whole Blood

    Time frame: Pre-dose (0 hours), 3, 6, 12, 18, 24, 36, and 48 hours post-Day 1 dose

  33. Oligoadenylate Synthetase 1 (OAS 1) Gene mRNA Levels in Whole Blood

    Time frame: Pre-dose (0 hours), 3, 6, 12, 18, 24, 36, and 48 hours post-Day 1 dose

  34. Toll-Like Receptor 7 (TLR7) Gene mRNA Levels in Whole Blood

    Time frame: Pre-dose (0 hours), 3, 6, 12, 18, 24, 36, and 48 hours post-Day 1 dose

  35. Tmax of Prodrug Metabolite RO6870868

    Time frame: Pre-dose (0 hour), 0.25, 0.5, 1, 1.5, 2, 3, 4, 8, 12, 18, 24, 36 and 48 hours post-Day 1 dose

  36. Serum Tumor Necrosis Factor Alpha Levels

    Time frame: Pre-dose (0 hours), 3, 6, 12, 18, 24, 36, and 48 hours post-Day 1 dose

Sponsors and collaborators

Lead sponsor

Hoffmann-La Roche

Industry

Registry information

Official study title

A Phase I, Randomized, Double-Blind, Placebo-Controlled, Single Ascending Dose Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of RO6864018 Following Oral Administration in Asian Healthy Subjects

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Dec 19, 2013
Registry last updated
Mar 1, 2017

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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