Overview

To Investigate the Gastrointestinal Behaviour of Two Triple Combination Products in Healthy Male Volunteers

Status:
Completed
Trial end date:
2018-03-29
Target enrollment:
0
Participant gender:
Male
Summary
This clinical study will be conducted to characterize the gastrointestinal transit of two multi-symptoms formulations by inclusion of a radiolabel marker.
Phase:
Phase 1
Accepts Healthy Volunteers?
Accepts Healthy Volunteers
Details
Lead Sponsor:
GlaxoSmithKline
Treatments:
Acetaminophen
Dextromethorphan
Oxymetazoline
Phenylephrine
Criteria
Inclusion Criteria:

- Evidence of a personally signed and dated informed consent document indicating that
the subject has been informed of all pertinent aspects of the study before any
assessment is performed.

- Healthy male participants who, at the time of screening, are between the ages of 21
and 45 years, inclusive.

- Participants who are willing and able to comply with scheduled visits, treatment plan,
bio-imaging procedure, laboratory tests and other study procedures.

- Healthy participant which is defined as in general good physical health, as judged by
the investigator and no clinically relevant abnormalities identified by a detailed
medical history, full physical examination, including blood pressure and pulse rate
measurement, 12-lead Electrocardiogram (ECG) or clinical laboratory tests.

- Body Mass Index (BMI) of 17.5 to 30.5 kilogram per meter square (kg/m2); and a total
body weight >50 kg (110 lbs)

Exclusion Criteria:

- Participants who are investigational site staff members directly involved in the
conduct of the study and their family members, site staff members otherwise supervised
by the investigator, or participants who are GSK employees directly involved in the
conduct of the study.

- Participation in other studies involving investigational drug(s) within 30 days prior
to study entry and/or during study participation.

- Acute or chronic medical or psychiatric condition 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
this study.

- Known or suspected intolerance or hypersensitivity or contraindication to the study
materials (or closely related compounds) or any of their stated ingredients.

- Participant with known allergy or intolerance to any of the contents of the standard
meals.

- Participant is vegetarian.

- Unwilling or unable to comply with the Lifestyle guidelines described in this
protocol.

- Use of prescription or non-prescription drugs and dietary supplements within 14 days
or 5 half-lives, whichever is longer, prior to the first dose of investigational
product that are deemed by the investigator to have a potential impact on the study
objectives results.

- Evidence or history of clinically significant laboratory abnormality, hematological,
renal, endocrine, pulmonary, cardiovascular, hepatic, psychiatric, neurologic, or
allergic disease within the last 5 years that may increase the risk associated with
study participation.

- A positive urine drug screen, breath alcohol test or urine cotinine test during
Screening or on Day -1 of the study.

- Any condition possibly affecting drug absorption (e.g., gastrectomy)

- A history of current or relevant previous non-self-limiting gastrointestinal disorders
peptic ulcer disease and/or gastrointestinal bleeding.

- Currently suffering from disease known to impact gastric emptying, e.g. migraine,
insulin-dependent diabetes mellitus.

- The participant has had radiation exposure from clinical trials, including from the
present study, and from therapeutic or diagnostic exposure, but excluding background
radiation, exceeding a target organ (colon) dose of 50 mSv (5 rems) from a single dose
within the last 30 days or a cumulative dose of 150 mSv (15 rems) in the last 12
months. No participant whose occupation requires monitoring for radiation exposure
will be enrolled in the study.

- Participants who have been exposed to ionising radiation in excess of 10 mSv (whole
body effective dose) above background over the previous 3 years period as a result of
occupational exposure or previous participation in research studies. Clinically
justified (therapeutic or diagnostic) exposures are not included in this calculation.

- Renal disease or impaired renal function at screening as indicated by abnormal levels
of serum creatinine or urea or the presence of clinically significant abnormal urinary
constituents (e.g. albuminuria). Minor deviations of laboratory values from the normal
range are permitted, if judged by the investigator to have no clinical relevance.

- History or current evidence of ongoing hepatic disease or impaired hepatic function at
screening. A candidate will be excluded if more than one of the following lab value
deviations are found: 1) AST/SGOT (≥ 1.2 ULN), ALT/SGPT (≥ 1.2 ULN), 2) GGT (≥ 1.2
ULN), ALP (≥ 1.2 ULN), 3) total bilirubin (≥ 1.2 mg/dL) Minor deviations of laboratory
values from the normal range are permitted, if judged by the investigator to have no
clinical relevance. Positive results in any of the virology tests for HIV-Ab, HCV-Ab,
HBsAg and HBc-Ab (Total).

- Diagnosis of long QT syndrome or QTc > 450 msec for males at screening.

- Participants who were intending to father a child in the 3 months following the study.

- Participants who were unwilling to follow contraception requirements

- Participant had any non-removable metal objects such as metal plates, screws etc. in
their chest or abdominal area.

- History of regular alcohol consumption exceeding 14 drinks/week (1 drink = 5 ounces
(150 mL) of wine or 12 ounces (360 mL) of beer or 1.5 ounces (45 mL) of hard liquor)
within 6 months of Screening.

- Smokers defined as the use of tobacco products (including but not limited to:
electronic-cigarettes, nicotine gums, nicotine lozenges, etc) during the 6 months
prior to screening or a positive urine cotinine test at screening.

- Participant has consumed (eat or drink) grapefruit or grapefruit-related citrus fruits
(e.g., Seville oranges, pomelos, pawpaw, dragon fruit, kiwi fruit, mango, passion
fruit, pomegranate, rambutan, star fruit or products that contain these fruits) 14
days prior to the first dose of investigational product.

- Participants who have previously been enrolled in this study.