TMC207-TiDP13-C110: Interaction Study With Lopinavir/Ritonavir in Healthy Volunteer

NCT00828529 | Completed Phase 1

• 1 other identifier: CR002545
• Study Type: interventional
• Target: 16
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of this Phase I, open-label, randomized crossover trial is to investigate the pharmacokinetic interaction between steady-state lopinavir/ritonavir and single-dose TMC207 in healthy volunteers.

Conditions

Tuberculosis; HIV

Keywords

TMC207-TiDP13-C110; TMC207-C110; TMC207; Drug-drug interaction; Tuberculosis; HIV; Kaletra; Lopinavir; Ritonavir; Open-label; HIV Infections

Outcome Measures

Primary Outcomes (1)

• The primary objective is to evaluate the effect of steady-state LPV/rtv 400/100 mg twice daily on the pharmacokinetics of TMC207 and its M2 metabolite after single-dose administration of TMC207 400 mg, in healthy volunteers.

Secondary Outcomes (1)

• The secondary objectives are: to evaluate the effect of single-dose TMC207 on the steady-state plasma concentrations of lopinavir and ritonavir in healthy volunteers; to evaluate the short-term safety and tolerability of co-administration of single-dose

Interventions

TMC207 DRUG

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Non-smoking or smoking no more than 10 cigarettes, or 2 cigars, or 2 pipes per day for at least 3 months prior to selection
• Body Mass Index of 18.0 to 32.0 kg/m2, extremes included
• Able to comply with protocol requirements
• Healthy on the basis of a physical examination, medical history, ECG, vital signs and the results of blood biochemistry and hematology test and a urinalysis carried out at screening
• Informed Consent Form signed voluntarily before the first trial-related activity.

You may not qualify if:

• A positive HIV-1 or HIV-2 test
• Female, except if postmenopausal since more than 2 years, or posthysterectomy, or post-surgical sterilization
• Hepatitis A, B, or C infection
• Evidence of current use of illicit drugs or opioids or abuse of alcohol
• Currently active or underlying disorders including gastrointestinal, cardiovascular, neurologic, psychiatric, metabolic, renal, hepatic, respiratory, inflammatory, or infectious disease
• Any history of significant skin disease or allergy including allergy or hypersensitivity to any of the excipients of the investigational medication administered in this trial
• Use of concomitant medication, including over-the-counter products and dietary supplements, except for ibuprofen and paracetamol up to 3 days before the first dose of trial medication
• Recent donation of blood or plasma or participation in a clinical trial
• Subjects with QTc prolongation or any other clinically significant ECG abnormality or a family history of Long QT Syndrome.

Sponsors & Collaborators

• Tibotec BVBA: lead

Related Publications (1)

• Svensson EM, Dooley KE, Karlsson MO. Impact of lopinavir-ritonavir or nevirapine on bedaquiline exposures and potential implications for patients with tuberculosis-HIV coinfection. Antimicrob Agents Chemother. 2014 Nov;58(11):6406-12. doi: 10.1128/AAC.03246-14. Epub 2014 Aug 11.

  PMID: 25114140 DERIVED

MeSH Terms

Conditions

Tuberculosis; HIV Infections

Interventions

bedaquiline

Condition Hierarchy (Ancestors)

Mycobacterium Infections; Actinomycetales Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Blood-Borne Infections; Communicable Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Study Officials

• Tibotec-Virco Virology BVBA Clinical Trial

  Tibotec BVBA

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: January 22, 2009
• First Posted: January 26, 2009
• Study Start: February 1, 2009
• Primary Completion: May 1, 2009
• Study Completion: May 1, 2009
• Last Updated: August 15, 2012

Record last verified: 2012-08