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

NCT02183584 | Completed Phase 1

• 1 other identifier: 1218.67
• Study Type: interventional
• Target: 16
• Locations: 0 countries
• Sites: N/A

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)

Conditions

Healthy

Outcome Measures

Primary Outcomes (2)

• Area under the steady state concentration-time curve of linagliptin in plasma (AUCτ,ss)

  up to 19 days

• Maximum measured steady state concentration of linagliptin in plasma (Cmax,ss)

  up to 19 days

Secondary Outcomes (12)

• Dipeptidyl-peptidase 4 (DPP-4) inhibition

  up to 19 days

• 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

  up to 19 days

• Cmax,ss (maximum measured concentration of the analyte in plasma at steady state over a uniform dosing interval τ) of CD 1790

  up to 19 days

• Ratio of urinary concentrations of 6β-hydroxycortisol to cortisol

  screening, days 1 and 6 of treatment A, days 4, 6, 8 and 12 of treatment B always in the morning before drug administration

• 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

  up to 19 days

Study Arms (1)

Rifampicin and Linagliptin

EXPERIMENTAL

Drug: Rifampicin; Drug: Linagliptin

Interventions

Rifampicin DRUG

Rifampicin and Linagliptin

Linagliptin DRUG

Rifampicin and Linagliptin

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Boehringer Ingelheim: lead

MeSH Terms

Interventions

Rifampin; Linagliptin

Intervention Hierarchy (Ancestors)

Rifamycins; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Lactams, Macrocyclic; Macrocyclic Compounds; Polycyclic Compounds; Purines; Heterocyclic Compounds, 2-Ring; Quinazolines

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 7, 2014
• First Posted: July 8, 2014
• Study Start: September 1, 2009
• Primary Completion: October 1, 2009
• Last Updated: July 8, 2014

Record last verified: 2014-07