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PEPI-TiDP23-C104 is a First in Human Study With a Single Dose Escalation Part and a Multiple Dosing Part for Compounds TMC589337 and TMC589354.

This study has been terminated.
(The premature end of this trial was a business decision and not due to safety or efficacy concerns of the compounds.)
Sponsor:
Information provided by:
Tibotec Pharmaceuticals, Ireland
ClinicalTrials.gov Identifier:
NCT00908414
First received: May 21, 2009
Last updated: April 26, 2010
Last verified: April 2010
History of Changes
  Purpose

The purpose of the study is to determine the safety, tolerability, and plasma pharmacokinetics (i.e., the levels of TMC589337 and TMC589354 circulating in your blood over time) of increasing single oral doses of TMC589337 and TMC589354 and of multiple increasing oral doses followed by a single dose of TMC310911 to assess the potential boosting effect on the latter compound. In this study 3 investigational new drugs are involved. These new investigational drugs called TMC589337 and TMC589354 (from the PEPI family) and TMC310911 are in process of development for the treatment of Human Immunodeficiency Virus-Type 1 (HIV-1). TMC589337 and TMC589354 are novel molecules with no antiviral activity to be used to enhance the pharmacokinetics profile of a drug. TMC310911 is a novel and potent compound and belong to a medication class called protease inhibitors (PI).


Condition Intervention Phase
HIV Infections
 Drug: TMC589337, TMC589354, TMC310911, placebo
 Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: Phase I, Double-blind, Randomized, Placebo-controlled Trial in Healthy Volunteers to Examine Safety, Tolerability, Plasma Pharmacokinetics of TMC589337&TMC589354 After Increasing Single Oral Doses & in an Open-label Part After Different Repeated Doses in Combination With Single Oral Dose of TMC310911

Resource links provided by NLM:

MedlinePlus related topics: HIV/AIDS
U.S. FDA Resources

Further study details as provided by Tibotec Pharmaceuticals, Ireland:

Primary Outcome Measures:
  • The trial objectives are to determine the safety, tolerability and plasma pk of TMC589337/TMC589354 after increasing single oral doses from 40 mg up to 400 mg and after increasing multiple oral doses. [ Time Frame: 8 weeks. This includes a treatment, washout and follow up period and is excluding screening period of maximum 21 days before first medication intake) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • The trial objectives are to determine the safety, tolerability and plasma pk interaction between TMC310911 and TMC589337 or TMC589354. [ Time Frame: 8 weeks. This includes a treatment, washout and follow up period and is excluding screening period of maximum 21 days before first medication intake) ] [ Designated as safety issue: No ]

Study Start Date: May 2009
Estimated Study Completion Date: October 2009
Estimated Primary Completion Date: October 2009 (Final data collection date for primary outcome measure)
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Nonsmokers for at least 3 months prior to selection
  • Weight as defined by a Body Mass Index (BMI, weight in kg divided by the square of height in meters) of 18.0 to 30.0 kg/m2, extremes included
  • Informed Consent Form (ICF) signed voluntarily
  • Able to comply with protocol requirements
  • Healthy on the basis of a pretrial physical examination, medical history, the results of blood biochemistry and hematology tests, a urinalysis, vital signs, and a 12-lead electrocardiogram (ECG).

Exclusion Criteria:

  • Past history of clinically significant heart arrhythmias (extrasystolic, tachycardia at rest)
  • having baseline prolongation of QTc interval > 450 ms, history of risk factors for Torsade de Pointes syndrome (hypokalemia, family history of long QT Syndrome)
  • Female, except if postmenopausal for more than 2 years, or posthysterectomy or postsurgical sterilization (without reversal operation)
  • Currently active clinically relevant or significant underlying gastrointestinal, cardiovascular, nervous system, psychiatric, metabolic, renal, hepatic, respiratory, inflammatory, or infectious disease
  • History of clinically relevant skin disease or allergy including drug allergy as well.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00908414

Sponsors and Collaborators
Tibotec Pharmaceuticals, Ireland
Investigators
Study Director: Tibotec Pharmaceuticals Limited Clinical Trial Tibotec Pharmaceutical Limited
  More Information

No publications provided

Responsible Party: Compound Development Team Leader, Tibotec Pharmaceuticals Limited, Ireland
ClinicalTrials.gov Identifier: NCT00908414     History of Changes
Other Study ID Numbers: CR016195
Study First Received: May 21, 2009
Last Updated: April 26, 2010
Health Authority: Ireland: Irish Agriculture and Food Development Authority

Keywords provided by Tibotec Pharmaceuticals, Ireland:
PEPI-TiDP23-C104
PEPI-C104
PEPI
TMC589337
 TMC589354
TMC310911
Healthy Volunteers

Additional relevant MeSH terms:
HIV Infections
Acquired Immunodeficiency Syndrome
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
 Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases

ClinicalTrials.gov processed this record on May 23, 2013