Phase 1
N=28
To Investigate the Gastrointestinal Behaviour of Two Triple Combination Products in Healthy Male Volunteers
Common Cold
Bottom Line
View on ClinicalTrials.gov: NCT03415243 ↗Enrolled (actual)
28
Serious AEs
0.0%
Results posted
Jun 2019
Primary outcome: Primary: Mean Time to Onset of Gastric Emptying — 1.107; 8.534 minutes
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 1
- Interventions
- Acetaminophen 650mg+Dextromethorphan 20mg+Phenylephrine 10mg (Drug); Acetaminophen 325mg+Dextromethorphan 10mg+Phenylephrine 5mg (Drug)
- Age
- Adult · 21+ yrs
- Sex
- Male
- Sponsor
- GlaxoSmithKline
- Primary completion
- Mar 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Time to Onset of Gastric Emptying |
1.107; 8.534 | — |
| PRIMARY Mean Time to Complete Gastric Emptying |
121.2; 65.3 | — |
| PRIMARY Mean Time for Gastric Emptying by Measuring 25 Percent Values |
12.614; 12.171 | — |
| PRIMARY Mean Time for Gastric Emptying by Measuring 50 Percent Values |
22.643; 16.134 | — |
| PRIMARY Mean Time for Gastric Emptying by Measuring 90 Percent Values |
84.929; 36.214 | — |
| PRIMARY Percentage of Radiolabeled Drug Remaining in the Stomach After 15 Minutes of Administration |
67.00; 49.77 | — |
| PRIMARY Percentage of Radiolabeled Drug Remaining in the Stomach After 30 Minutes of Administration |
33.24; 20.87 | — |
| PRIMARY Percentage of Radiolabeled Drug Remaining in the Stomach After 45 Minutes of Administration |
24.79; 7.21 | — |
| PRIMARY Percentage of Radiolabeled Drug Remaining in the Stomach After 60 Minutes of Administration |
20.07; 4.26 | — |
| PRIMARY Percentage of Radiolabeled Drug Remaining in the Stomach After 75 Minutes of Administration |
14.73; 3.28 | — |
| PRIMARY Percentage of Radiolabeled Drug Remaining in the Stomach After 90 Minutes of Administration |
8.84; 2.45 | — |
| PRIMARY Percentage of Radiolabeled Drug Remaining in the Stomach After 105 Minutes of Administration |
6.06; 1.72 | — |
| PRIMARY Percentage of Radiolabeled Drug Remaining in the Stomach After 120 Minutes of Administration |
4.34; 0.99 | — |
| PRIMARY Percentage of Radiolabeled Drug Remaining in the Stomach After 180 Minutes of Administration |
0.64; 0.00 | — |
| PRIMARY Percentage of Radiolabeled Drug Remaining in the Stomach After 240 Minutes of Administration |
0.00; 0.00 | — |
| PRIMARY Area Under the Gastric Emptying Curve From Time 0 to 15 Minutes |
19.38; 16.96 | — |
| PRIMARY Area Under the Gastric Emptying Curve From Time 0 to 30 Minutes |
31.16; 25.11 | — |
| PRIMARY Area Under the Gastric Emptying Curve From Time 0 to 45 Minutes |
38.36; 28.19 | — |
| PRIMARY Area Under the Gastric Emptying Curve From Time 0 to 60 Minutes |
43.69; 29.60 | — |
| PRIMARY Area Under the Gastric Emptying Curve From Time 0 to 75 Minutes |
48.71; 30.61 | — |
| PRIMARY Area Under the Gastric Emptying Curve From Time 0 to 90 Minutes |
51.32; 31.29 | — |
| PRIMARY Area Under the Gastric Emptying Curve From Time 0 to 105 Minutes |
53.16; 31.81 | — |
| PRIMARY Area Under the Gastric Emptying Curve From Time 0 to 120 Minutes |
54.49; 32.15 | — |
| PRIMARY Area Under the Gastric Emptying Curve From Time 0 to 180 Minutes |
56.69; 32.61 | — |
| PRIMARY Area Under the Gastric Emptying Curve From Time 0 to 240 Minutes |
56.80; 32.61 | — |
| PRIMARY Total Area Under the Gastric Emptying Curve |
56.80; 32.61 | — |
| PRIMARY Gastric Emptying Half-Life |
25.00; 5.00 | — |
| PRIMARY Small Intestine Transit Time |
184.0; 139.5 | — |
| SECONDARY Number of Participants With Clinically Significant Change in Laboratory Test Values |
0; 0 | — |
Summary
This clinical study will be conducted to characterize the gastrointestinal transit of two multi-symptoms formulations by inclusion of a radiolabel marker.
Eligibility 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 t
Data sourced from ClinicalTrials.gov (NCT03415243). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.