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Comparison of the Pharmacokinetic Properties of Two Tablet Formulations of Macitentan in Healthy Adults

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ClinicalTrials.gov Identifier: NCT02476864
Recruitment Status : Completed
First Posted : June 22, 2015
Last Update Posted : April 22, 2016
Sponsor:
Information provided by (Responsible Party):
Actelion

Brief Summary:
A study conducted in healthy adults to investigate if a new macitentan tablet leads to the same fate of macitentan in the body (time of onset, time of presence, amount in the blood) as the marketed macitentan tablet.

Condition or disease Intervention/treatment Phase
Healthy Subjects Drug: Treatment A (adult formulation) Drug: Treatment B (pediatric formulation) Phase 1

Detailed Description:

The purpose of this study is to establish biocomparison of 2 types of tablets containing macitentan: a pediatric dispersible tablet and the adult film-coated tablet. A single oral dose of each tablet will be given to healthy subjects on 2 different periods separated by a washout phase of 10 to 14 days.

Biocomparison will be based on the comparison of the pharmacokinetic parameters of macitentan with the two types of tablets using specific statistical methods. The pharmacokinetic parameters will be considered equivalent if specific criteria defined in the study protocol are met.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 12 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Official Title: Single-center, Open-label, Randomized, Two-treatment, Single-dose, Crossover Study in Healthy Subjects to Investigate the Biocomparison of the Adult and Pediatric Formulation of Macitentan
Study Start Date : August 2015
Actual Primary Completion Date : December 2015
Actual Study Completion Date : December 2015

Resource links provided by the National Library of Medicine

Drug Information available for: Macitentan

Arm Intervention/treatment
Experimental: Sequence AB
Subjects receive treatment A in Period 1 followed by treatment B in Period 2 with a washout phase of 10 to 14 days between the two treatment periods
Drug: Treatment A (adult formulation)
Single oral administration of one film-coated tablet containing 10 mg of macitentan as active substance and lactose, magnesium stearate, microcrystalline cellulose, povidone, sodium starch glycolate type A, polysorbate as inactive ingredients.The film coat contains titanium dioxide, talc, xanthan gum, polyvinyl alcohol, and soy lecithin.
Other Name: Opsumit

Drug: Treatment B (pediatric formulation)
Single oral administration of two dispersible tablets, each containing 5 mg of macitentan as active ingredient and Mannitol delta polymorphic crystals, mannitol, isomalt, isomalt agglomerated, croscarmellose sodium, and magnesium stearate as inactive ingredients.

Experimental: Sequence BA
Subjects receive treatment B in Period 1 followed by treatment A in Period 2 with a washout phase of 10 to 14 days between the two treatment periods
Drug: Treatment A (adult formulation)
Single oral administration of one film-coated tablet containing 10 mg of macitentan as active substance and lactose, magnesium stearate, microcrystalline cellulose, povidone, sodium starch glycolate type A, polysorbate as inactive ingredients.The film coat contains titanium dioxide, talc, xanthan gum, polyvinyl alcohol, and soy lecithin.
Other Name: Opsumit

Drug: Treatment B (pediatric formulation)
Single oral administration of two dispersible tablets, each containing 5 mg of macitentan as active ingredient and Mannitol delta polymorphic crystals, mannitol, isomalt, isomalt agglomerated, croscarmellose sodium, and magnesium stearate as inactive ingredients.




Primary Outcome Measures :
  1. Plasma pharmacokinetic profile [ Time Frame: From pre-dose to 216 hours post-dose ]
    Pharmacokinetic profile will be determined by the following parameters: Cmax (Maximum plasma concentration), tmax (Time to reach Cmax), t1/2 (Terminal half-life), AUC(0-t) (Area under the plasma concentration-time curve from zero to time t of the last measured concentration above the limit of quantification), AUC(0-inf) (Area under the plasma concentration-time curve from zero to infinity)


Other Outcome Measures:
  1. Incidence of adverse events [ Time Frame: from baseline to Day 10-13 post-dose ]
    Number of adverse events and serious adverse events, including abnormal laboratory findings

  2. ECG abnormalities [ Time Frame: from baseline to to Day 10-13 post-dose ]
    ECG evaluation will be based on the cardiac rhythms measured using a standard 12-lead ECG device



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Signed informed consent
  • Healthy on the basis of the physical examination, vital signs (systolic and diastolic blood pressure, heart rate), 12-lead ECG, and laboratory tests performed at screening

Exclusion Criteria:

  • History or clinical evidence of any disease and/or condition, which might interfere with the absorption, distribution, metabolism or excretion of the study drug
  • Previous history of fainting, collapse, syncope, orthostatic hypotension, or vasovagal reactions
  • History or clinical evidence of alcoholism or drug abuse within the 3 -year period prior to screening
  • Excessive caffeine consumption
  • Smoking within 3 months prior to screening and inability to refrain from smoking during the course of the study
  • Previous treatment with any prescribed medications (including vaccines) or over-the counter medications within 2 weeks prior to first study drug administration
  • Loss of 250 mL or more of blood within 3 months prior to screening
  • Any circumstances or conditions, which, in the opinion of the investigator, may affect full participation in the study or compliance with the protocol

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02476864


Locations
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Czech Republic
CEPHA s.r.o.
Pilsen, Czech Republic, 323 00
Sponsors and Collaborators
Actelion
Investigators
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OverallOfficial: Patricia Sidharta, PharmD, PhD Actelion

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Responsible Party: Actelion
ClinicalTrials.gov Identifier: NCT02476864     History of Changes
Other Study ID Numbers: AC-055-121
2015-001623-23 ( EudraCT Number )
First Posted: June 22, 2015    Key Record Dates
Last Update Posted: April 22, 2016
Last Verified: April 2016
Keywords provided by Actelion:
macitentan
biocomparison
safety
Additional relevant MeSH terms:
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Macitentan
Endothelin A Receptor Antagonists
Endothelin Receptor Antagonists
Molecular Mechanisms of Pharmacological Action
Endothelin B Receptor Antagonists