Study in Healthy Male Subjects to Evaluate the Effect of Itraconazole and Rifampicin on the PK of Fedovapagon

NCT02440841 | Completed Phase 1

• 1 other identifier: 483-010
• Study Type: interventional
• Target: 29
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to investigate the potential for co-administration of strong inhibitors or inducers of CYP3A4 to alter the pharmacokinetics of fedovapagon.

Conditions

Nocturia

Keywords

VA106483; fedovapagon; drug-drug interaction; DDI; males; rifampicin; rifampin; itraconazole; CYP3A4; pharmacokinetics; PK

Outcome Measures

Primary Outcomes (1)

• Plasma fedovapagon concentration in presence and absence of co-administered itraconazole or rifampicin

  10-12 days

Secondary Outcomes (6)

• Maximum observed plasma concentration (Cmax)

  10-12 days

• Area under the plasma concentration curve versus time curve with extrapolation to infinity (AUC(0-infinity))

  10-12 days

• Number and type of adverse events

  12-14 days

• Change from baseline in 12-lead ECG

  12-14 days

• Change from baseline in vital signs and physical examination

  12-14 days

Study Arms (2)

fedovapagon and itraconazole

EXPERIMENTAL

Two daily doses of fedovapagon and once daily doses of itraconazole

Drug: fedovapagon; Drug: Itraconazole

fedovapagon and rifampicin

EXPERIMENTAL

Two daily doses of fedovapagon and once daily doses of rifampicin

Drug: fedovapagon; Drug: rifampicin

Interventions

fedovapagon DRUG

fedovapagon and itraconazole; fedovapagon and rifampicin

Itraconazole DRUG

fedovapagon and itraconazole

rifampicin DRUG

fedovapagon and rifampicin

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy males aged 18 to 45
• Have a body mass index between 18 and 29.9 kg/m2 (weight: ≥50 kg and ≤100 kg)
• No clinically significant medical history
• Ability to comply with the requirements of the study
• Provide written informed consent
• Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) should be below or equal to upper level of normal (ULN). Otherwise liver enzymes should show no clinical significant abnormalities. Total bilirubin should not exceed 1.5 x ULN. Liver enzymes will be re-tested only once before randomization if required.
• Be judged by the Investigator to be in good health based on medical history (in particular, no congestive heart failure, ischemic heart disease, valvular heart disease, significant pulmonary disease, renal failure, edematous disorder, liver disease, gastric disorders, porphyria, diabetes mellitus or hereditary disorders of carbohydrate metabolism), physical examination, vital sign measurements and laboratory safety tests
• Agree to refrain from the consumption of grapefruit or grapefruit juice, apple or orange juice, vegetables from the mustard green family (e.g., kale, broccoli, watercress, collard greens, kohlrabi, brussels sprouts, mustard) and charbroiled meats containing products beginning 1 week prior to administration of the initial administration of trial drug, throughout the trial
• Use of any prescribed medication or St John's Wort within 14 days (or 5 half-lives if this is longer) or over-the-counter medication (except paracetamol) within 1 week of dosing. Specific medication not to be taken within 2 weeks of (before or after) administration of itraconazole is described in the Summary of Product Characteristic for Sempera®

Sponsors & Collaborators

• Vantia Ltd: lead

Study Sites (1)

PAREXEL Early Phase Clinical Unit Berlin

Berlin, 14050, Germany

Location

MeSH Terms

Conditions

Nocturia

Interventions

Itraconazole; Rifampin

Condition Hierarchy (Ancestors)

Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Triazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Piperazines; Rifamycins; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Lactams, Macrocyclic; Macrocyclic Compounds; Polycyclic Compounds

Study Officials

• Tshibuabua Kabasela

  Parexel

  STUDY DIRECTOR

Study Design

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

Study Record Dates

• First Submitted: May 7, 2015
• First Posted: May 12, 2015
• Study Start: May 1, 2015
• Primary Completion: July 1, 2015
• Study Completion: July 1, 2015
• Last Updated: July 30, 2015

Record last verified: 2015-07

Locations

DE (1)