AzTrials
AzTrials

Non-Alcoholic SteatohepatitisPhase 1NCT02571192

A Study to Investigate How the Study Drug SHP626 is Eliminated From the Body After One Dose

A Phase 1 study testing SHP626 and 5.95 μCi RAD in people with Non-Alcoholic Steatohepatitis, run by Mirum Pharmaceuticals, Inc. at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

The purpose of this study is to determine how SHP626 is absorbed and excreted from the body in healthy males. Read more about this study

Who is it for?
Ages 18 to 50 years, men onlyHealthy volunteers can take part
Conditions the study is for
Non-Alcoholic Steatohepatitis
What is being tested?
SHP626 and 5.95 μCi RAD
Could I receive a placebo?
No, everyone receives an active treatment
How many people
8 participants
Where
1 siteUnited States
Study dates
1 Oct 2015to 1 Oct 2015
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 50 years
  • Men only
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Age between 18 and 50 years, inclusive, at the time of consent.
  • Must be considered healthy. Healthy status is defined by absence of evidence of any active or chronic disease following a detailed medical and surgical history, a complete physical examination including vital signs, 12-lead ECG, hematology, thyroid panel (includes T3, T4 and TSH at Screening only), blood chemistry, coagulation and urinalysis
  • Must have a body mass index between 18.0-30.0kg/m² inclusive with a body weight >50 kg (110 lbs).
  • Ability to swallow all investigational product.
  • A minimum of 1 bowel movement per day.

Who cannot join

  • History of any hematological, hepatic, respiratory, cardiovascular, renal, neurological or psychiatric disease, gallbladder removal, gastric bypass surgery, ileal resection, any small intestinal resection,or current or recurrent disease that could affect the action, absorption, or disposition of the investigational product, or clinical or laboratory assessments.
  • Current or relevant history of physical or psychiatric illness.
  • Known or suspected intolerance or hypersensitivity to the investigational product, or closely-related compounds, or any of the stated ingredients.
  • Significant illness, as judged by the investigator, within 2 weeks of the dose of investigational product.
  • Known history of alcohol or other substance abuse within the last year.
  • Donation of blood or blood products (eg, plasma or platelets) within 60 days prior to the dose of investigational product.
Show all 21Show fewer
  • Within 30 days prior to the dose of investigational product:
  • Have used an investigational product (if elimination half-life is <6 days, otherwise 5 half-lives).
  • Have been enrolled in a clinical study (including vaccine studies) that, in the investigator's opinion, may impact this Shire-sponsored study.
  • Have had any substantial changes in eating habits, as assessed by the investigator.
  • Confirmed systolic blood pressure >139mmHg or <89mmHg, and diastolic blood pressure >89mmHg or <49mmHg.
  • Twelve-lead ECG demonstrating QTc >450 msec at screening. If QTc exceeds 450msec, the ECG should be repeated 2 more times and the average of the 3 QTc values should be used to determine the subject's eligibility.
  • A positive screen for drugs of abuse at Screening or a positive screen for alcohol or drugs of abuse at Check-in (Day -1).
  • Male subjects who consume more than 21 units of alcohol per week or 3 units of alcohol per day.
  • A positive human immunodeficiency virus antibody screen, hepatitis B surface antigen, or hepatitis C virus antibody screen.
  • Use of tobacco in any form
  • Routine consumption of more than 2 units of caffeine per day
  • Current use of any medication including over-the-counter, herbal, or homeopathic preparations
  • An inability to follow a standardized diet and meal schedule or inability to fast
  • Have participated in a [14C]-study within the last 6 months prior to the dose of investigational product.
  • Exposure to clinically significant radiation within 12 months prior to the dose of investigational product

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Covance Madison Clinical Research Unit

    Madison, Wisconsin, 53704

Other trials in United States

About this study

Official title: A Phase 1, Open-label Study to Investigate the Absorption, Distribution, Metabolism, and Excretion of [14C]-SHP626 Following a Single Oral Dose in Healthy Male Subjects

The purpose of this study is to determine how SHP626 is absorbed and excreted from the body in healthy males.

Being tested
SHP626, 5.95 μCi RAD
Keywords
ADME
Medical subject headings
Non-alcoholic Fatty Liver Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SHP626Drug

    single oral dose 50mg SHP626 with approximately 5.95 μCi RAD

  • 5.95 μCi RADRadiation

Study groups in NCT02571192
Study groupRoleWhat they receive
Experimental DrugExperimentalsingle oral dose radiolabelled 50mg of SHP626
Receives: Drug: SHP626; Radiation: 5.95 μCi RAD

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Pharmacokinetic parameters will be determined from the plasma and blood concentration time data of total radioactivity and from the plasma concentration-time data for SHP626 by non-compartmental analysis.

    Measured: Day 1 to day 10

  2. Total radioactivity (RAD) in whole blood and plasma

    Measured: Day 1 to day 10

  3. To determine the total RAD in urine and feces.

    Measured: Day 1 to day 10

  4. Maximum plasma concentration (Cmax) of 50mg [14C]-SHP626 and RAD occurring at time of maximum observed concentration (tmax)

    Measured: Day 1 to day 10

  5. Area under the plasma concentration curve (AUC0-t) of 50mg [14C]-SHP626 and RAD from the time of dosing to the last measurable concentration

    Measured: Day 1 to Day 10

  6. Area under the plasma concentration curve (AUC0-∞ ) of 50mg [14C]-SHP626 and RAD extrapolated to infinity, calculated using the observed value of the last non-zero plasma concentration

    Measured: Day 1 to Day 10

  7. First order rate constant associated with the terminal portion of the plasma curve terminal half-life (t½) for 50mg [14C]-SHP626 and RAD

    Measured: Day 1 to Day 10

  8. Total body clearance (CL/F ) of 50mg [14C]-SHP626 and RAD for extravascular administration divided by the fraction of dose absorbed

    Measured: Day 1-10

  9. Volume of distribution (Vz/F ) of 50mg [14C]-SHP626 and RAD associated with the terminal slope following extra-vascular administration divided by the fraction of dose absorbed

    Measured: Day 1-10

  10. Cumulative amount (Aef )of RAD recovered in stool over the dosing interval

    Measured: Day 1-10

  11. Excreted Percent of RAD recovered in stool over the dosing interval

    Measured: Day 1-10

  12. Cumulative amount (Aeu ) of RAD recovered in urine over the dosing interval

    Measured: Day 1-10

  13. Excreted Percent of RAD recovered in urine over the dosing interval

    Measured: Day 1-10

  14. Renal Clearance (CLR ) of 50mg [14C]-SHP626

    Measured: Day 1 -10

Secondary outcomes (10)

  1. Characterize and identify metabolites of [14C]-SHP626 in plasma by accelerator mass spectrometry for radioactivity quantification

    Metabolites in the excreta and/or plasma will then be structurally identified by a combination of techniques such as co-chromatography with authentic reference standards, high performance liquid chromatography-mass spectrometry, and other spectroscopic techniques if necessary

    Measured: Day 1 to day 10

  2. Characterize and identify metabolites of [14C]-SHP626 in urine by accelerator mass spectrometry for radioactivity quantification

    Metabolites in the excreta and/or plasma will then be structurally identified by a combination of techniques such as co-chromatography with authentic reference standards, high performance liquid chromatography-mass spectrometry, and other spectroscopic techniques if necessary

    Measured: Day 1 to day 10

  3. Characterize and identify metabolites of [14C]-SHP626 in feces by liquid scintillation counting

    Metabolites in the excreta and/or plasma will then be structurally identified by a combination of techniques such as co-chromatography with authentic reference standards, high performance liquid chromatography-mass spectrometry, and other spectroscopic techniques if necessary

    Measured: Day 1 to day 10

  4. Assess the safety and tolerability of [14C]-SHP626 by adverse events (AEs) defined as changes, including changes from baseline in physical examination findings

    AEs will be coded using the agreed upon version of MedDRA. The number of events, incidence, and percentage of TEAEs will be calculated overall, by system organ class and by preferred term. TEAEs will be further summarized by severity and relationship to investigational product. AEs related to investigational product, AEs leading to withdrawal, SAEs, and deaths will be similarly summarized/listed.

    Measured: Screening to day 7

  5. Changes from baseline in vital signs

    Measured: Screening to day 7

  6. Changes from baseline in ECGs

    Measured: Screening to day 7

  7. Changes from baseline in hematology

    Measured: Screening to day 7

  8. Changes from baseline in coagulation

    Measured: Screening to day 7

  9. Changes in baseline in urinalysis

    Measured: Screening to day 7

  10. Changes in baseline in chemistry

    Measured: Screening to day 7

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Oct 2015 (estimated)
  2. Study start1 Oct 2015
  3. Primary completion1 Oct 2015
  4. Study completion1 Oct 2015

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Basic science
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
8 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02571192
Sponsor's protocol ID
SHP626-102
Status last verified
Apr 2019
First submitted
30 Sep 2015
Last updated
1 May 2019
Results posted
No
Data monitoring committee
No

Publications

  • Siebers N, Palmer M, Silberg DG, Jennings L, Bliss C, Martin PT. Absorption, Distribution, Metabolism, and Excretion of [14C]-Volixibat in Healthy Men: Phase 1 Open-Label Study. Eur J Drug Metab Pharmacokinet. 2018 Feb;43(1):91-101. doi: 10.1007/s13318-017-0429-7.

    PubMed 28702877

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing SHP626 and 5.95 μCi RAD in people with Non-Alcoholic Steatohepatitis, run by Mirum Pharmaceuticals, Inc. at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 1 May 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Pharmacokinetic parameters will be determined from the plasma and blood concentration time data of total radioactivity and from the plasma concentration-time data for SHP626 by non-compartmental analysis. (time frame: Day 1 to day 10). The study lists 14 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02571192, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 May 2019.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in