Last updated: 11/07/2018 09:40:59
RES115596: Estimation of Skeletal Muscle Mass with D3 Creatine Pharmacokinetic Study in Healthy VolunteersD3 creatine
Clinicaltrials.gov ID
Not applicable
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Completed
Completed
Trial overview
Official title: RES115596: Estimation of Skeletal Muscle Mass with D3 Creatine Pharmacokinetic Study in Healthy Volunteers
Trial description: The purpose of this study is to estimate total body muscle mass through measurement of total creatinie pool sizes.
Primary purpose:
Not applicable
Trial design:
Single Group Assignment
Masking:
None (Open Label)
Allocation:
Non-randomized
Primary outcomes:
D3 creatinine in urine
Timeframe: 5 Days
Secondary outcomes:
Creatine pool size
Timeframe: 5 days
D3 creatine in urine
Timeframe: 5 days
e. LCMS
Timeframe: 5 days
Crreatine pool size
Timeframe: 5 days
Cmax, Tmax, t½, AUCt, AUC-infinity
Timeframe: 12-72 hours
Crreatine pool size
Timeframe: 5 days
DEXA, MRI, enrichment, creatinine excretion
Timeframe: 5 days
Interventions:
Dietary: D3 creatine
Enrollment:
35
Observational study model:
Case-Only
Primary completion date:
Not applicable
Time perspective:
Prospective
Clinical publications:
Clark RV, Walker AC, O'Connor-Semmes RL, Leonard MS, Miller RR, Stimpson SA, Turner SM, Ravussin E, Cefalu WT, Hellerstein M, Evans WJ. Total body skeletal muscle mass: estimation by creatine (methyl-d3) dilution in humans.. J Appl Physiol. 2014;116(12)(June 15, 2014):1605-13.
Medical condition
Atrophy, Muscular
Product
CCI21130
Collaborators
Not applicable
Study date(s)
September 2011 to December 2012
Type
Interventional
Phase
1
Participation criteria
Sex
Female & Male
Age
18 - 65 Year
Accepts healthy volunteers
yes
- Healthy as determined by a responsible MD
- Males between 18 and 30 and postmenopausal females between 50 and 65 years of age, inclusive
- Current or chronic history of liver or biliary disease (with the exception of Gilbert's syndrome or asymptomatic gallstones).
- Any positive test for HIV antibody or Hepatitis B surface antigen, or for Hepatitis C antibody within 3 months of screening.
Inclusion and exclusion criteria
Inclusion criteria:
- Healthy as determined by a responsible MD
- Males between 18 and 30 and postmenopausal females between 50 and 65 years of age, inclusive
- BMI within range of 21-32 kg/m2
- Capable of giving written informed consnet
Exclusion criteria:
- Current or chronic history of liver or biliary disease (with the exception of Gilbert's syndrome or asymptomatic gallstones).
- Any positive test for HIV antibody or Hepatitis B surface antigen, or for Hepatitis C antibody within 3 months of screening.
- Renal impairment as defined by a calculated GFR < 60 mL/min
- AST, ALT, alkaline phosphatase and bilirubin greater than or equal to 1.5 times upper limit of notmal (isolated bilirubin greater than 1.5 itimes upper limit of notmal s acceptable if bilirubin is fractionated and direct bilirubin < 35%).
- Significant ECG abnormalities at Screening or Baseline
- Systolic blood pressure greater than 160 mmHg, or diastolic blood pressure greater than 100 mmHg at Screening.
- History of regular alcohol consumption within 6 months of the study
- The subject has participated in a clinical trial and has received an investigational product within the following time period prior to the first dosing day in the current study: 30 days, 5 half-lives or twice the duration of the biological effect of the investigational product (whichever is longer).
- Exposure to more than four new chemical entities within 12 months prior to the first dosing day.
- Use of creatine supplements within 3 months of dosing
- Use of prescription or non-prescription drugs, including vitamins, herbal and dietary supplements, unless in the opinion of the Investigator and GSK Medical Monitor the medication will not interfere with the study procedures or compromise subject safety..
- Where participation in the study would result in donation of blood or blood products in excess of 500 mL within a 56 day period.
- History of sensitivity to heparin or heparin-induced thrombocytopenia.
- A positive pre-study drug/alcohol screen. Urinary cotinine levels indicative of smoking or history or regular use of tobacco- or nicotine-containing products within 6 months prior to screening..
- Subjects currently on Atkins or high animal protein diets (e.g. >120 g/day of protein for men; > 80 g/day protein for women) or low animal protein diets (e.g vegetarians or vegans)
- Any other condition that in the opinion of the Investigator and Medical Monitor would exclude the subject from participation
Trial location(s)
No location data available.
Study documents
Scientific result summary
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Refer to study documents
Recruitment status
Completed
Actual primary completion date
Not applicable
Actual study completion date
2012-19-12
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
Additional information about the trial
Additional information
Not applicable
Participate in clinical trial
Access to clinical trial data by researchers
Visit website