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Trial record 61 of 1163 for:    MYCOPHENOLIC ACID

A Phase I DDI Study Between ACH-0144471 and Midazolam, Fexofenadine and Mycophenolate Mofetil

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ClinicalTrials.gov Identifier: NCT03108274
Recruitment Status : Completed
First Posted : April 11, 2017
Last Update Posted : June 16, 2017
Sponsor:
Information provided by (Responsible Party):
Achillion Pharmaceuticals

Brief Summary:
The purpose of this study is to determine the potential drug interaction between ACH-0144471 and Midazolam, Fexofenadine and Mycophenolate Mofetil

Condition or disease Intervention/treatment Phase
Drug Interaction Potentiation Drug: Part 1, Period 1 Drug: Part 1, Period 2 Drug: Part 2, Period 1 Drug: Part 2, Period 2 Drug: Part 3, Period 1 Drug: Part 3, Period 2 Phase 1

Detailed Description:
This will be a 3-part study with each part being an open-label, fixed sequence, 2-treatment study in healthy adult subjects. Part 1, Part 2 and Part 3 may be conducted concurrently or separately and the order of the parts may be determined accordingly to the needs of the ACH-0144471 development program. A total of 12 subjects will participate in each study part.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 35 participants
Allocation: Randomized
Intervention Model: Sequential Assignment
Intervention Model Description: This will be a 3-part study with each part being an open-label, fixed sequence, 2-treatment study in healthy adult subjects. Part 1, Part 2 and Part 3 may be conducted concurrently or separately and the order of the parts may be determined according to the needs of the ACH-0144471 development program
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Three-Part Phase I Study to Determine the Potential Drug Interaction Between ACH-0144471 and Midazolam, Fexofenadine and Mycophenolate Mofetil in Healthy Subjects
Actual Study Start Date : April 18, 2017
Actual Primary Completion Date : June 2, 2017
Actual Study Completion Date : June 16, 2017


Arm Intervention/treatment
Experimental: Part 1, Period 1
Single oral dose of Midazolam Day 1
Drug: Part 1, Period 1
Midazolam single oral dose
Other Name: Midazolam

Experimental: Part 1, Period 2
Multiple oral doses of ACH-0144471 Day 1-4 Single oral single dose of Midazolam on Day 4
Drug: Part 1, Period 2
Multiple doses ACH-0144471 Single dose Midazolam
Other Names:
  • ACH-0144471
  • Midazolam

Experimental: Part 2, Period 1
Single dose of Fexofenadine on Day 1
Drug: Part 2, Period 1
Fexofenadine single oral dose
Other Name: Fexofenadine

Experimental: Part 2, Period 2
Multiple doses of ACH-0144471 on Days 1-6 Single dose of Fexofenadine on Day 4
Drug: Part 2, Period 2
Multiple doses ACH-0144471 Single dose Fexofenadine
Other Names:
  • ACH-0144471
  • Fexofenadine

Experimental: Part 3, Period 1
Single dose of Mycophenolate Mofetil on Day 1
Drug: Part 3, Period 1
Mycophenolate Mofetil single oral dose
Other Name: Mycophenolate Mofetil

Experimental: Part 3, Period 2
Multiple doses of ACH-0144471 on Days 1-6 Single dose of Mycophenolate Mofetil on Day 4
Drug: Part 3, Period 2
Multiple doses ACH-0144471 Single dose Mycophenolate Mofetil
Other Names:
  • ACH-0144471
  • Mycophenolate




Primary Outcome Measures :
  1. Drug Interaction Between ACH-0144471 and Midazolam, Fexofenadine and Mycophenolate Mofetil [ Time Frame: Up to 26 Days ]
    To determine the effect of multiple oral doses of ACH-0144471 on the pharmacokinetics (PK) of midazolam, fexofenadine and mycophenolic acid (MPA) and mycophenolic acid glucuronide (MPAG) as measured by maximum observed concentration (Cmax)

  2. Drug Interaction Between ACH-0144471 and Midazolam, Fexofenadine and Mycophenolate Mofetil [ Time Frame: Up to 26 Days ]
    To determine the effect of multiple oral doses of ACH-0144471 on the pharmacokinetics (PK) of midazolam, fexofenadine and mycophenolic acid (MPA) and mycophenolic acid glucuronide (MPAG) as measured by area under the curve (AUC)


Secondary Outcome Measures :
  1. Drug Interaction Between ACH-0144471 and Midazolam [ Time Frame: Up to 26 Days ]
    To assess the safety and tolerability of multiple oral doses of ACH-0144471 with midazolam measured by adverse events (AE's), physical examinations (PE), vital signs (VS), laboratory safety tests, urinalysis and 12-lead electrocardiograms (ECG)

  2. Drug Interaction Between ACH-0144471 and Fexofenadine [ Time Frame: Up to 26 Days ]
    To assess the safety and tolerability of multiple oral doses of ACH-0144471 with fexofenadine measured by adverse events (AE's), physical examinations (PE), vital signs (VS), laboratory safety tests, urinalysis and 12-lead electrocardiograms (ECG)

  3. Drug Interaction Between ACH-0144471 and Mycophenolate Mofetil [ Time Frame: Up to 26 Days ]
    To assess the safety and tolerability of multiple oral doses of ACH-0144471 with mycophenolate mofetil measured by adverse events (AE's), physical examinations (PE), vital signs (VS), laboratory safety tests, urinalysis and 12-lead electrocardiograms (ECG)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy male and female subjects age 18-60
  • Have a BMI of 18.5 to 32 kg/m2 with a minimum body weight of 50kg
  • Females must be of non-childbearing potential
  • Males must agree to use effective contraception during and for 90 days after last dose of study drug
  • Willing to answer inclusion and exclusion criteria
  • Give voluntary consent
  • Willing to comply with visit schedule and all procedures and tests

Exclusion Criteria:

  • Mentally or legally incapacitated or significant emotional problems
  • History of disease
  • Any condition which might interfere with drug absorption
  • Positive test for HIV, Hepatitis B and/or C
  • History of sensitivity to study medication, or other drug allergy
  • Body temperature greater than 38 Celsius
  • History of febrile illness within 14 days of first dose
  • History of meningococcal infection
  • Positive urine drug test
  • Current tobacco users and smokers
  • Consumption of alcohol within 72 hours of study drug administration
  • Participated in another clinical study within 28 days prior to first dose
  • Previous participation in an ACH-0144471 study
  • 12-lead ECG with significant findings
  • Significant laboratory abnormalities
  • Use of prescription medications within 14 days of first dose
  • Use of medications known to induce hepatic microsomal enzyme cytochrome
  • Prior history or current evidence of biliary cholestasis
  • Blood donation of more than 500mL within 3 months of first dose
  • Received a blood transfusion or blood products within 6 months to first dose
  • Unwilling or unable to comply with study protocol
  • Males subjects with female partner who is pregnant, nursing or planning to become pregnant within 90 days of last study dose
  • Received live attenuated vaccine within 30 days or other vaccine within 14 days of first dose
  • Have or history of Gilberts syndrome

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): NCT03108274


Locations
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New Zealand
Auckland Clinical Studies
Auckland, New Zealand, 1150
Sponsors and Collaborators
Achillion Pharmaceuticals
Investigators
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Principal Investigator: Paul Hamilton, MD Auckland Clinical Studies Limited

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Responsible Party: Achillion Pharmaceuticals
ClinicalTrials.gov Identifier: NCT03108274     History of Changes
Other Study ID Numbers: ACH471-010
U1111-1193-2774 ( Other Identifier: Universal Trial Number (UTN) )
First Posted: April 11, 2017    Key Record Dates
Last Update Posted: June 16, 2017
Last Verified: June 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes

Keywords provided by Achillion Pharmaceuticals:
Midazolam
Fexofenadine
Mycophenolate Mofetil

Additional relevant MeSH terms:
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Mycophenolic Acid
Midazolam
Fexofenadine
Terfenadine
Adjuvants, Anesthesia
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Anti-Anxiety Agents
Tranquilizing Agents
Psychotropic Drugs
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
GABA Modulators
GABA Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Antibiotics, Antineoplastic
Antineoplastic Agents
Antibiotics, Antitubercular
Antitubercular Agents
Anti-Bacterial Agents
Anti-Infective Agents
Enzyme Inhibitors
Anti-Allergic Agents
Histamine H1 Antagonists, Non-Sedating
Histamine H1 Antagonists
Histamine Antagonists
Histamine Agents