Study to Investigate the Influence of Hepatic Insufficiency on the Pharmacokinetics of Tozadenant
Status: | Terminated |
---|---|
Conditions: | Gastrointestinal |
Therapuetic Areas: | Gastroenterology |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 1/6/2018 |
Start Date: | June 30, 2017 |
End Date: | December 31, 2017 |
A Two-Part, Open-Label, Single-Dose Study to Investigate the Influence of Hepatic Insufficiency on the Pharmacokinetics of Tozadenant
This is a two-part, open label, single-dose study that will evaluate the PK of tozadenant in
subjects with different degrees of hepatic impairment to the PK of a single-dose of
tozadenant in healthy subjects.
subjects with different degrees of hepatic impairment to the PK of a single-dose of
tozadenant in healthy subjects.
Inclusion Criteria:
All subjects must fulfill the following to participate:
- Subject has given his/her written informed consent on an IEC or IRB approved consent
form.
- Subject understands the study procedures in the informed consent form (ICF), and is
willing and able to comply with the protocol.
- Be either male or female 18 years old
- Have a BMI ≥ 18.5 and ≤ 40.0 kg/m2 at screening
- Is a continuous non-smoker or a smoker who will consume up to 10 cigarettes/day
- Child bearing females should be sexually inactive (abstinent) prior to dosing
- Females subjects of non childbearing potential must have undergone one of the
following sterilization or be postmenopausal
Subjects with mild, moderate, or severe hepatic impairment must:
- Have a medical history consistent with a diagnosis of hepatic impairment.
- Have a diagnosis of chronic (> 6 months), stable hepatic insufficiency
Healthy subjects must be:
- Medically healthy with no significant medical history
Exclusion Criteria:
Subjects must not be enrolled in the study if they:
- Previously participated in any study with tozadenant
- Has orthostatic hypotension, history or symptoms of cardiovascular disease, or
hypertensive crisis.
- Currently participating in or has participated in another study and received drug
(active or placebo)
- Have a known diagnosis of malignant melanoma
- Have a current episode of major depression
- Has a recent history of suicide attempt
- Has any other condition or clinically significant abnormal findings on the physical or
neurological examination, psychiatric and medical history
- Had surgery or any medical condition within 6 months
- Unable to refrain from or anticipates the use of any drugs, vitamins, natural or
herbal supplements
- Subject is currently lactating or pregnant or planning to become pregnant.
- Recent donation of blood, plasma or significant blood loss
- Has positive test for ethanol or drugs of abuse or a history of chronic alcohol or
drug abuse
- Clinically significant medical history
- Positive results hepatitis B surface antigen (HBsAg) or hepatitis C virus (HCV) for
Healthy Volunteers only.
We found this trial at
2
sites
5055 South Orange Ave Orlando FL 32909
Orlando, Florida 32806
Orlando, Florida 32806
407-240-7878
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University of Miami A private research university with more than 15,000 students from around the...
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