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CompletedNCT01591850Updated Nov 2, 2016

A Drug-Drug Interaction Study of Ketoconazole, Rifampicin and Ritonavir-Boosted Atazanavir With Single-Dose RO5093151 in Healthy Volunteers

A Phase 1 interventional study of RO5093151 and atazanavir in Healthy Volunteer, sponsored by Hoffmann-La Roche. Completed at 1 site in United States. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2016-11-02.

Sponsored by Hoffmann-La Roche · Phase 1 and Interventional

Phase
Phase 1
Study type
Interventional
Enrollment
51
Ages
18 Years to 65 Years
Sex
All
01

Study summary

This randomized, single-center, open-label, one-sequence, two-period crossover study in three parts will assess the effects of multiple doses of ketoconazole, rifampicin and ritonavir-boosted atazanavir on the pharmacokinetics of a single dose of RO5093151 in healthy male and female volunteers. In Period 1, subjects will receive a single oral dose of RO5093151. In Period 2, subjects will receive a single oral dose of RO5093151 and multiple oral doses of either ketoconazole, rifampicin or ritonavir-boosted atazanavir. Anticipated time on study is up to 8.5 weeks.

02

Conditions studied

  • Healthy Volunteer
03

In context

Lead sponsor

Hoffmann-La Roche is the lead sponsor of 2,061 studies on the registry; 85 are open to participants now.

Of its 319 completed or terminated interventional studies of FDA-regulated products, 239 (75%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • Healthy male and female subjects, 18 to 65 years of age. Healthy status is defined by absence of evidence of any active or chronic disease following a detailed medical and surgical history and complete physical examination
  • Body mass index (BMI) 18 to 30 kg/m2
  • Females of child-bearing potential must agree to use two effective methods of contraception, including a barrier method and an intrauterine non-hormonal device (set in place at least 3 months before first dosing) for the duration of the study and at least 1 month after last dosing
  • Non-smoker for at least 90 days prior to screening

Exclusion criteria

Exclusion Criteria:

  • Pregnant or lactating females
  • History of drug abuse in the past 2 years, or suspicion of regular consumption of drugs of abuse, or positive result on drugs of abuse test
  • History of alcoholism in the past 2 years, or positive alcohol test
  • Positive for hepatitis B, hepatitis C or HIV infection
  • Systemic , topical, intranasal or inhaled corticosteroid therapy for more than 2 weeks within 3 months prior to screening
  • Participation in an investigational drug or device study within 90 days prior to screening
05

Study design

Phase
Phase 1
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
51 participants (actual)

Study arms

  • Experimental
    1 Ketoconazole DDI

    Drug: RO5093151 · Drug: ketoconazole

  • Experimental
    2 Rifampicin DDI

    Drug: RO5093151 · Drug: rifampicin

  • Experimental
    3 ATZ/r DDI

    Drug: RO5093151 · Drug: atazanavir · Drug: ritonavir

Interventions

  • DrugRO5093151

    Single oral dose

  • Drugatazanavir

    Multiple oral doses

  • Drugketoconazole

    Multiple oral doses

  • Drugrifampicin

    Multiple oral doses

  • Drugritonavir

    Multiple oral doses

06

What researchers measure

Primary outcomes

  1. Part 1: Effect of multiple doses of ketoconazole on single-dose pharmacokinetics of RO5093151 and metabolites: Area under the concentration-time curve (AUC)

    Time frame: Pre-dose and up to 72 hours post-dose

  2. Part 2: Effect of multiple doses of rifampicin on single-dose pharmacokinetics of RO5093151 and metabolites: Area under the concentration-time curve (AUC)

    Time frame: Pre-dose and up to 72 hours post-dose

  3. Part 3: Effect of multiple doses of ritonavir-boosted atazanavir on single-dose pharmacokinetics of RO5093151 and metabolites: Area under the concentration-time curve (AUC)

    Time frame: Pre-dose and up to 72 hours post-dose

Secondary outcomes

  1. Safety: Incidence of adverse events

    Time frame: approximately 6 month

  2. RO5093151 metabolites: Plasma/urine concentrations

    Time frame: Pre-dose and up to 72 hours post-dose

  3. Pharmacodynamics: Area under the effect curve (AUEC) for plasma cortisol/cortisone (Part 1 only)

    Time frame: Pre-dose and up to 24 hours post-dose

07

Study locations

1 site
  • Merritt Island, Florida 32953, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 2, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01591850
Lead sponsor
Hoffmann-La Roche
Responsible party
Sponsor
First posted
May 4, 2012
Start date
Sep 2011
Primary completion
Nov 2011
Completion
Nov 2011
Last update
Nov 2, 2016

Study contacts

Clinical Trials
study director · Hoffmann-La Roche
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Nov 2016. You cannot join it, but the record below documents what was studied.

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