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Study to Evaluate the Effect of Multiple Doses of Rifampicin on the Multiple-dose Pharmacokinetics of Linagliptin in Healthy Volunteers

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ClinicalTrials.gov Identifier: NCT02183584
Recruitment Status : Completed
First Posted : July 8, 2014
Last Update Posted : July 8, 2014
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim

Brief Summary:
Investigation of the bioavailability of linagliptin after concomitant multiple oral administration of 5 mg linagliptin tablets and 600 mg rifampicin (Treatment A) in comparison to multiple oral administration of 5 mg linagliptin tablets given alone (Treatment B)

Condition or disease Intervention/treatment Phase
Healthy Drug: Rifampicin Drug: Linagliptin Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 16 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open Label, Two-period, Fixed Sequence, Phase 1 Trial to Evaluate the Effect of Multiple Doses of Rifampicin on the Multiple-dose Pharmacokinetics of Linagliptin
Study Start Date : September 2009
Actual Primary Completion Date : October 2009

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Rifampicin and Linagliptin Drug: Rifampicin
Drug: Linagliptin



Primary Outcome Measures :
  1. Area under the steady state concentration-time curve of linagliptin in plasma (AUCτ,ss) [ Time Frame: up to 19 days ]
  2. Maximum measured steady state concentration of linagliptin in plasma (Cmax,ss) [ Time Frame: up to 19 days ]

Secondary Outcome Measures :
  1. Dipeptidyl-peptidase 4 (DPP-4) inhibition [ Time Frame: up to 19 days ]
  2. AUCτ,ss (area under the concentration-time curve of the analyte in plasma at steady state over a uniform dosing interval τ) of CD 1790 [ Time Frame: up to 19 days ]
  3. Cmax,ss (maximum measured concentration of the analyte in plasma at steady state over a uniform dosing interval τ) of CD 1790 [ Time Frame: up to 19 days ]
  4. Ratio of urinary concentrations of 6β-hydroxycortisol to cortisol [ Time Frame: screening, days 1 and 6 of treatment A, days 4, 6, 8 and 12 of treatment B always in the morning before drug administration ]
  5. Aet1-t2,ss ( amount of analyte that is eliminated in urine from the time point t1 to time point t2 under steady state conditions) of linagliptin [ Time Frame: up to 19 days ]
  6. fet1-t2,ss ( fraction of administered drug excreted unchanged in urine at steady state over the respective time interval, where t1 and t2 define beginning and end times of the time interval) of linagliptin [ Time Frame: up to 19 days ]
  7. Number of patients with adverse events [ Time Frame: up to 42 days ]
  8. Assessment of global tolerability by investigator on a 4-point scale [ Time Frame: up to 21 days after last drug administration ]
  9. Number of patients with abnormal findings in physical examination [ Time Frame: up to 21 days after last drug administration ]
  10. Number of patients with abnormal changes in laboratory parameters [ Time Frame: up to 21 days after last drug administration ]
  11. Number of patients with clinically significant changes in Vital signs (Blood Pressure (BP), Pulse Rate (PR)) [ Time Frame: up to 21 days after last drug administration ]
  12. Number of patients with clinically significant changes in 12-lead ECG (electrocardiogram) [ Time Frame: up to 21 days after last drug administration ]


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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy males and females according to the following criteria: Based upon a complete medical history, including the physical examination, vital signs (Blood Pressure (BP), Pulse Rate (PR)), 12-lead Electrocardiogram (ECG), clinical laboratory tests
  • Age 18 to 50 years (incl.)
  • BMI 18.5 to 29.9 kg/m2 (incl.)
  • Signed and dated written informed consent prior to admission to the study in accordance with Good clinical practice (GCP) and the local legislation

Exclusion Criteria:

  • Any finding of the medical examination (including BP, PR and ECG) deviating from normal and of clinical relevance
  • Any evidence of a clinically relevant concomitant disease
  • Gastrointestinal, hepatic (incl. porphyrias), renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
  • Surgery of the gastrointestinal tract (except appendectomy)
  • Diseases of the central nervous system (such as epilepsy) or psychiatric disorders or neurological disorders
  • History of relevant orthostatic hypotension, fainting spells or blackouts.
  • Chronic or relevant acute infections
  • History of relevant allergy or hypersensitivity (including allergy to drug or its excipients)
  • Intake of drugs with a long half-life (more than 24 hours) within at least one month or less than 10 half-lives of the respective drug prior to administration or during the trial
  • Participation in another trial with an investigational drug within two months prior to administration or during the trial
  • Smoker (more than 10 cigarettes or more than 3 cigars or more than 3 pipes/day)
  • Inability to refrain from smoking on trial days
  • Alcohol abuse (more than 30 g/day if male, more than 20 g/day if female)
  • Drug abuse
  • Blood donation (more than 100 mL within four weeks prior to administration or during the trial)
  • Excessive physical activities (within one week prior to administration or during the trial)
  • Any laboratory value outside the reference range that is of clinical relevance
  • Inability to comply with dietary regimen of trial site
  • Thrombocytopenia or increased liver function tests (i.e. Alanine transaminase (ALT), Aspartate transaminase (AST), bilirubin, Alkaline phosphatase (AP), Gamma-glutamyl transferase (GGT)) at screening
  • prior rifampicin exposure

For female subjects:

  • Positive pregnancy test, pregnancy or planning to become pregnant during the study or within 2 months after study completion
  • No adequate contraception during the study and until 1 month after study completion, i.e. not any of the following: IUD (intrauterine device), sexual abstinence for at least 1 month prior to enrolment, vasectomised partner (vasectomy performed at least 1 year prior to enrolment), or surgical sterilisation (including hysterectomy). Females, who do not have a vasectomised partner, are not sexually abstinent or surgically sterile have to use an additional barrier method (e.g. condom, diaphragm with spermicide)
  • Lactation

Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT02183584     History of Changes
Other Study ID Numbers: 1218.67
First Posted: July 8, 2014    Key Record Dates
Last Update Posted: July 8, 2014
Last Verified: July 2014

Additional relevant MeSH terms:
Linagliptin
Rifampin
Hypoglycemic Agents
Physiological Effects of Drugs
Incretins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Dipeptidyl-Peptidase IV Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antibiotics, Antitubercular
Antitubercular Agents
Anti-Bacterial Agents
Anti-Infective Agents
Leprostatic Agents
Nucleic Acid Synthesis Inhibitors
Cytochrome P-450 CYP2B6 Inducers
Cytochrome P-450 Enzyme Inducers
Cytochrome P-450 CYP2C8 Inducers
Cytochrome P-450 CYP2C19 Inducers
Cytochrome P-450 CYP2C9 Inducers
Cytochrome P-450 CYP3A Inducers