ABOUT THIS STUDY
Age and Sex:
1. Male and female participants must be 18 to 55 years of age, inclusive, at the time of signing the informed consent document (ICD).
• Refer to Appendix 4 for reproductive criteria for male (Section 10.4.1) and female (Section 10.4.2) participants.
Type of Participant and Disease Characteristics:
2. Male and female participants who are overtly healthy as determined by medical evaluation including a detailed medical history, full physical examination, including blood pressure (BP) and pulse rate (PR) measurement, chest radiograph (posteroanterior), 12 lead electrocardiogram (ECG), and clinical laboratory tests.
3. Participants who are willing and able to comply with all scheduled visits, treatment plan, laboratory tests, lifestyle considerations, and other study procedures.
4. Participants must be of Chinese ethnicity (individuals currently residing in mainland China who were born in China and have both parents of Chinese descent).
5. Body mass index (BMI) of 18 to 28 kg/m2, inclusive; and a total body weight >50 kg for males and >=45 kg for females.
6. Capable of giving signed informed consent as described in Appendix 1, which includes compliance with the requirements and restrictions listed in the informed consent document (ICD) and in this protocol.
7. Participants need to be CYP2D6 non-poor metabolizer (which includes EM, IM and UM) as confirmed by genotype (see Section 8.7.1).
1. Evidence or history of clinically significant hematological, renal, endocrine,
pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurological, or
allergic disease (including drug allergies, but excluding untreated, asymptomatic,
seasonal allergies at the time of dosing).
2. Any condition possibly affecting drug absorption (eg, gastrectomy, cholecystectomy,
3. History of human immunodeficiency virus (HIV) infection, hepatitis B, or hepatitis C;
positive testing for HIV, hepatitis B surface antigen (HepBsAg), hepatitis B surface
antibody (HepBsAb); hepatitis B virus e antigen (HepBeAg); hepatitis B virus e
antibody (HepBeAb); hepatitis B core antibody (HepBcAb), hepatitis C antibody (HCVAb)
or treponema pallidum antibody (TPPA). Hepatitis B vaccination is allowed.
4. Other acute or chronic medical or psychiatric condition including recent (within the
past year) or active suicidal ideation or behavior or laboratory abnormality that may
increase the risk associated with study participation or investigational product
administration or may interfere with the interpretation of study results and, in the
judgment of the investigator, would make the participant inappropriate for entry into
5. Use of prescription or nonprescription drugs and dietary and herbal supplements within
7 days or 5 half lives (whichever is longer) prior to the first dose of
investigational product. (Refer to Section 6.5 for additional details).
6. Taking any medicinal product that changes the activity of hepatic enzymes within 28
days prior to Screening, such as inducer of CYP2D6.
Prior/Concurrent Clinical Study Experience:
7. Previous administration with an investigational drug within 30 days (or as determined
by the local requirement) or 5 half lives preceding the first dose of investigational
product used in this study (whichever is longer).
8. A positive urine drug screen.
9. Screening supine blood pressure (BP) >=140 mm Hg (systolic) or >= 90 mm Hg
(diastolic), following at least 5 minutes of supine rest. If BP is >= 140 mm Hg
(systolic) or >= 90 mm Hg (diastolic), the BP should be repeated 2 more times and the
average of the 3 BP values should be used to determine the participant's eligibility.
10. Baseline 12 lead electrocardiogram (ECG) that demonstrates clinically relevant
abnormalities that may affect participant safety or interpretation of study results
(eg, baseline corrected QT (QTc) interval >450 millisecond [msec], complete left
bundle branch block [LBBB], signs of an acute or indeterminate age myocardial
infarction, ST T interval changes suggestive of myocardial ischemia, second or third
degree atrioventricular [AV] block, or serious bradyarrhythmias or tachyarrhythmias).
If the baseline uncorrected QT interval is >450 msec, this interval should be rate
corrected using the Fridericia method and the resulting corrected QT (QTcF) should be
used for decision making and reporting. If QTc exceeds 450 msec, or QRS exceeds 120
msec, the ECG should be repeated 2 more times and the average of the 3 QTc or QRS
values should be used to determine the participant's eligibility. Computer interpreted
ECGs should be overread by a physician experienced in reading ECGs before excluding
11. History of alcohol abuse or binge drinking and/or any other illicit drug use or
dependence within 6 months of Screening. Binge drinking is defined as a pattern of 5
(male) and 4 (female) or more alcoholic drinks in about 2 hours. As a general rule,
alcohol intake should not exceed 14 units per week (1 unit = 8 ounces (240 mL) beer, 1
ounce (30 mL) of 40% spirit or 3 ounces (90 mL) of wine).
12. Use of tobacco- or nicotine-containing products in excess of the equivalent of 5
cigarettes per day within 3 months of Screening; a positive urine nicotine test.
13. Blood donation (excluding plasma donations) of approximately 400 mL or more within 60
days prior to dosing.
14. History of sensitivity to heparin or heparin induced thrombocytopenia.
15. History of hypersensitivity to the active substance or to ergot alkaloids, or to any
of the excepients.
16. Unwilling or unable to comply with the criteria in the Lifestyle Considerations
section of this protocol.
17. Investigator site staff members directly involved in the conduct of the study and
their family members, site staff members otherwise supervised by the investigator, or
Pfizer employees, including their family members, directly involved in the conduct of
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