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NCT Number: NCT01099904

A Study on the Effect of Renal Function on the Pharmacakokinetics of RO5024048 (Parent of Prodrug RO5024048) Following Multiple Oral Dose Administration of RO5024048

This open-label, parallel group study will evaluate the effect of renal function on the pharmacokinetics of RO4995855 following multiple oral dose administration of RO5024048 and assess the effect of renal impairment on safety and tolerability of RO5024048. Adult males or females with either normal renal function or mild or moderate renal impairment will receive RO5024048 orally for 5 days. Target sample size is <50.

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Key information

Conditions

Healthy Volunteer

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Christchurch, New Zealand

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Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • male or female adults, 18-75 years of age
  • normal, or mildly or moderately impaired renal function (creatinine clearance >/= 30 mL/min)
  • BMI 18-40 kg/m2
  • stable renal function
  • agree to abstain from alcohol consumption during study drug adminsitration and limit consumption up to the end of the study
  • agree to abstain from coffein consumption throughout study

Exclusion criteria

  • positive urine or blood test for drugs of abuse not under a physician's prescription
  • positive for HIV or HCV, or HBV with clinical symptoms or history of hepatitis
  • uncontrolled hypertension
  • renal transplant, dialysis patient, nephritic syndrome
  • clinically significant cardiovascular, central nervous system, gastrointestinal or liver disease or disorder

Treatment and study plan

RO5024048

Drug

multiple oral doses for 5 days

Primary outcomes

  1. Phrmacokinetics of RO49958855 (parent molecule) and metabolites following multiple doses of RO5024048: AUC, Cmax, Tmax T1/2, Ae, Cl

    Time frame: sampling days 1 and 3-11

Secondary outcomes

  1. Effect of renal impairment on safety and tolerability: Adverse events, vital signs, ECG, laboratory parameters

    Time frame: Throughout study, ECG and laboratory assessments days 3, 5, 6 and 17

Sponsors and collaborators

Lead sponsor

Hoffmann-La Roche

Industry

Registry information

Official study title

The Effect of Renal Function on the Pharmacokinetics of RO4995855 (Parent of ProDrug RO5024048) Following Multiple Oral Dose Administration of RO5024048

Important dates

Study start
2010
Primary completion
2010
Study completion
2010
First posted
Apr 8, 2010
Registry last updated
Nov 2, 2016

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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