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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02571192
Other study ID # SHP626-102
Secondary ID
Status Completed
Phase Phase 1
First received
Last updated
Start date October 1, 2015
Est. completion date October 1, 2015

Study information

Verified date April 2019
Source Mirum Pharmaceuticals, Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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


Recruitment information / eligibility

Status Completed
Enrollment 8
Est. completion date October 1, 2015
Est. primary completion date October 1, 2015
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Male
Age group 18 Years to 50 Years
Eligibility Inclusion Criteria:

1. Age between 18 and 50 years, inclusive, at the time of consent.

2. 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

3. Must have a body mass index between 18.0-30.0kg/m² inclusive with a body weight >50 kg (110 lbs).

4. Ability to swallow all investigational product.

5. A minimum of 1 bowel movement per day.

Exclusion Criteria:

1. 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.

2. Current or relevant history of physical or psychiatric illness.

3. Known or suspected intolerance or hypersensitivity to the investigational product, or closely-related compounds, or any of the stated ingredients.

4. Significant illness, as judged by the investigator, within 2 weeks of the dose of investigational product.

5. Known history of alcohol or other substance abuse within the last year.

6. Donation of blood or blood products (eg, plasma or platelets) within 60 days prior to the dose of investigational product.

7. 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.

8. Confirmed systolic blood pressure >139mmHg or <89mmHg, and diastolic blood pressure >89mmHg or <49mmHg.

9. 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.

10. A positive screen for drugs of abuse at Screening or a positive screen for alcohol or drugs of abuse at Check-in (Day -1).

11. Male subjects who consume more than 21 units of alcohol per week or 3 units of alcohol per day.

12. A positive human immunodeficiency virus antibody screen, hepatitis B surface antigen, or hepatitis C virus antibody screen.

13. Use of tobacco in any form

14. Routine consumption of more than 2 units of caffeine per day

15. Current use of any medication including over-the-counter, herbal, or homeopathic preparations

16. An inability to follow a standardized diet and meal schedule or inability to fast

17. Have participated in a [14C]-study within the last 6 months prior to the dose of investigational product.

18. Exposure to clinically significant radiation within 12 months prior to the dose of investigational product

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
SHP626
single oral dose 50mg SHP626 with approximately 5.95 µCi RAD
Radiation:
5.95 µCi RAD


Locations

Country Name City State
United States Covance Madison Clinical Research Unit Madison Wisconsin

Sponsors (1)

Lead Sponsor Collaborator
Mirum Pharmaceuticals, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. Day 1 to day 10
Primary Total radioactivity (RAD) in whole blood and plasma Day 1 to day 10
Primary To determine the total RAD in urine and feces. Day 1 to day 10
Primary Maximum plasma concentration (Cmax) of 50mg [14C]-SHP626 and RAD occurring at time of maximum observed concentration (tmax) Day 1 to day 10
Primary Area under the plasma concentration curve (AUC0-t) of 50mg [14C]-SHP626 and RAD from the time of dosing to the last measurable concentration Day 1 to Day 10
Primary Area under the plasma concentration curve (AUC0-8 ) of 50mg [14C]-SHP626 and RAD extrapolated to infinity, calculated using the observed value of the last non-zero plasma concentration Day 1 to Day 10
Primary First order rate constant associated with the terminal portion of the plasma curve terminal half-life (t½) for 50mg [14C]-SHP626 and RAD Day 1 to Day 10
Primary Total body clearance (CL/F ) of 50mg [14C]-SHP626 and RAD for extravascular administration divided by the fraction of dose absorbed Day 1-10
Primary 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 Day 1-10
Primary Cumulative amount (Aef )of RAD recovered in stool over the dosing interval Day 1-10
Primary Excreted Percent of RAD recovered in stool over the dosing interval Day 1-10
Primary Cumulative amount (Aeu ) of RAD recovered in urine over the dosing interval Day 1-10
Primary Excreted Percent of RAD recovered in urine over the dosing interval Day 1-10
Primary Renal Clearance (CLR ) of 50mg [14C]-SHP626 Day 1 -10
Secondary 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 Day 1 to day 10
Secondary 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 Day 1 to day 10
Secondary 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 Day 1 to day 10
Secondary 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. Screening to day 7
Secondary Changes from baseline in vital signs Screening to day 7
Secondary Changes from baseline in ECGs Screening to day 7
Secondary Changes from baseline in hematology Screening to day 7
Secondary Changes from baseline in coagulation Screening to day 7
Secondary Changes in baseline in urinalysis Screening to day 7
Secondary Changes in baseline in chemistry Screening to day 7
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