Trial Outcomes & Findings for Pharmacodynamic Study of Two Lanthanum Carbonate Formulations in Healthy Adults (NCT NCT00880750)
NCT ID: NCT00880750
Last Updated: 2021-06-11
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
72 participants
Primary outcome timeframe
Continuous collection over 3 days
Results posted on
2021-06-11
Participant Flow
Participant milestones
| Measure |
Lanthanum Carbonate Granules First
Granule formulation first at 1000 mg three times a day for 3 days and a single 1000 mg dose after breakfast on Day 4, a washout period, then chewable tablet formulation at 1000 mg three times a day for 3 days and a single 1000 mg dose after breakfast on Day 4.
|
Lanthanum Carbonate Chewable Tablet First
Chewable tablet formulation first at 1000 mg three times a day for 3 days and a single 1000 mg dose after breakfast on Day 4, a washout period, then granule formulation at 1000 mg three times a day for 3 days and a single 1000 mg dose after breakfast on Day 4.
|
|---|---|---|
|
First Intervention
STARTED
|
39
|
33
|
|
First Intervention
COMPLETED
|
30
|
32
|
|
First Intervention
NOT COMPLETED
|
9
|
1
|
|
Washout Period
STARTED
|
30
|
32
|
|
Washout Period
COMPLETED
|
30
|
32
|
|
Washout Period
NOT COMPLETED
|
0
|
0
|
|
Second Intervention
STARTED
|
30
|
32
|
|
Second Intervention
COMPLETED
|
26
|
30
|
|
Second Intervention
NOT COMPLETED
|
4
|
2
|
Reasons for withdrawal
| Measure |
Lanthanum Carbonate Granules First
Granule formulation first at 1000 mg three times a day for 3 days and a single 1000 mg dose after breakfast on Day 4, a washout period, then chewable tablet formulation at 1000 mg three times a day for 3 days and a single 1000 mg dose after breakfast on Day 4.
|
Lanthanum Carbonate Chewable Tablet First
Chewable tablet formulation first at 1000 mg three times a day for 3 days and a single 1000 mg dose after breakfast on Day 4, a washout period, then granule formulation at 1000 mg three times a day for 3 days and a single 1000 mg dose after breakfast on Day 4.
|
|---|---|---|
|
First Intervention
Adverse Event
|
1
|
0
|
|
First Intervention
Unable to collect urine
|
4
|
0
|
|
First Intervention
Non-compliance with meals
|
0
|
1
|
|
First Intervention
Withdrawal by Subject
|
2
|
0
|
|
First Intervention
Lost to Follow-up
|
2
|
0
|
|
Second Intervention
Withdrawal by Subject
|
2
|
2
|
|
Second Intervention
Protocol Violation
|
1
|
0
|
|
Second Intervention
Unable to collect urine
|
1
|
0
|
Baseline Characteristics
Pharmacodynamic Study of Two Lanthanum Carbonate Formulations in Healthy Adults
Baseline characteristics by cohort
| Measure |
Lanthanum Carbonate Granules First
n=39 Participants
Granule formulation first at 1000 mg three times a day for 3 days and a single 1000 mg dose after breakfast on Day 4, a washout period, then chewable tablet formulation at 1000 mg three times a day for 3 days and a single 1000 mg dose after breakfast on Day 4.
|
Lanthanum Carbonate Chewable Tablet First
n=33 Participants
Chewable tablet formulation first at 1000 mg three times a day for 3 days and a single 1000 mg dose after breakfast on Day 4, a washout period, then granule formulation at 1000 mg three times a day for 3 days and a single 1000 mg dose after breakfast on Day 4.
|
Total
n=72 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
39 Participants
n=93 Participants
|
33 Participants
n=4 Participants
|
72 Participants
n=27 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Age, Continuous
|
31.5 years
STANDARD_DEVIATION 8.70 • n=93 Participants
|
31.3 years
STANDARD_DEVIATION 7.83 • n=4 Participants
|
31.4 years
STANDARD_DEVIATION 8.26 • n=27 Participants
|
|
Sex: Female, Male
Female
|
11 Participants
n=93 Participants
|
9 Participants
n=4 Participants
|
20 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
28 Participants
n=93 Participants
|
24 Participants
n=4 Participants
|
52 Participants
n=27 Participants
|
|
Region of Enrollment
United States
|
39 Participants
n=93 Participants
|
33 Participants
n=4 Participants
|
72 Participants
n=27 Participants
|
PRIMARY outcome
Timeframe: Continuous collection over 3 daysPopulation: Pharmacodynamic Set (PD) includes all subjects who completed all urine collections and consumed at least 95% of food in all treatment periods. Subjects who vomited from days -2 to 4 of any treatment period were excluded from the set.
Outcome measures
| Measure |
Lanthanum Carbonate Granules
n=49 Participants
Granule formulation at 1000 mg three times a day for 3 days and a single 1000 mg dose after breakfast on Day 4
|
Lanthanum Carbonate Chewable Tablet
n=49 Participants
Chewable tablet formulation at 1000 mg three times a day for 3 days and a single 1000 mg dose after breakfast on Day 4
|
|---|---|---|
|
Urinary Phosphate Excretion 3-Day Average
|
16.01 mmol
Standard Error 0.485
|
17.35 mmol
Standard Error 0.484
|
SECONDARY outcome
Timeframe: Continuous collection on Day 4Population: PD set
Outcome measures
| Measure |
Lanthanum Carbonate Granules
n=49 Participants
Granule formulation at 1000 mg three times a day for 3 days and a single 1000 mg dose after breakfast on Day 4
|
Lanthanum Carbonate Chewable Tablet
n=49 Participants
Chewable tablet formulation at 1000 mg three times a day for 3 days and a single 1000 mg dose after breakfast on Day 4
|
|---|---|---|
|
Urinary Phosphate Excretion on Day 4
|
15.03 mmol
Standard Error 0.569
|
17.01 mmol
Standard Error 0.569
|
SECONDARY outcome
Timeframe: 3, 4, 5, 6, 8, 12, 18, 24, 36 and 48 hours post-dose on Day 4Population: Pharmacokinetic set (PK) includes all subjects who had sufficient post-dose blood samples taken to estimate Cmax and AUC 0-48 hours after dosing on Day 4 in all treatment periods. Subjects who vomited between dosing and 10 hours post-dose on Day 4 of any treatment period were excluded from the PK set.
Outcome measures
| Measure |
Lanthanum Carbonate Granules
n=62 Participants
Granule formulation at 1000 mg three times a day for 3 days and a single 1000 mg dose after breakfast on Day 4
|
Lanthanum Carbonate Chewable Tablet
n=58 Participants
Chewable tablet formulation at 1000 mg three times a day for 3 days and a single 1000 mg dose after breakfast on Day 4
|
|---|---|---|
|
Area Under the Steady-state Plasma Concentration-time Curve (AUC) of Lanthanum Carbonate
|
14.2 ng*h/ml
Standard Deviation 6.02
|
10.3 ng*h/ml
Standard Deviation 3.50
|
SECONDARY outcome
Timeframe: 3, 4, 5, 6, 8, 12, 18, 24, 36 and 48 hours post-dose on Day 4Population: PK set
Outcome measures
| Measure |
Lanthanum Carbonate Granules
n=64 Participants
Granule formulation at 1000 mg three times a day for 3 days and a single 1000 mg dose after breakfast on Day 4
|
Lanthanum Carbonate Chewable Tablet
n=58 Participants
Chewable tablet formulation at 1000 mg three times a day for 3 days and a single 1000 mg dose after breakfast on Day 4
|
|---|---|---|
|
Maximum Plasma Concentration (Cmax) of Lanthanum Carbonate
|
0.638 ng/ml
Standard Deviation 0.241
|
0.504 ng/ml
Standard Deviation 0.181
|
SECONDARY outcome
Timeframe: 3, 4, 5, 6, 8, 12, 18, 24, 36 and 48 hours post-dose on Day 4Population: PK set
Outcome measures
| Measure |
Lanthanum Carbonate Granules
n=64 Participants
Granule formulation at 1000 mg three times a day for 3 days and a single 1000 mg dose after breakfast on Day 4
|
Lanthanum Carbonate Chewable Tablet
n=58 Participants
Chewable tablet formulation at 1000 mg three times a day for 3 days and a single 1000 mg dose after breakfast on Day 4
|
|---|---|---|
|
Time of Maximum Plasma Concentration (Tmax) of Lanthanum Carbonate
|
4.00 hours
Full Range 0.0 • Interval 0.0 to 6.0
|
4.00 hours
Full Range 0.0 • Interval 0.0 to 8.0
|
Adverse Events
Lanthanum Carbonate Granules
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
Lanthanum Carbonate Chewable Tablet
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Lanthanum Carbonate Granules
n=71 participants at risk
Granule formulation at 1000 mg three times a day for 3 days and a single 1000 mg dose after breakfast on Day 4
|
Lanthanum Carbonate Chewable Tablet
n=61 participants at risk
Chewable tablet formulation at 1000 mg three times a day for 3 days and a single 1000 mg dose after breakfast on Day 4
|
|---|---|---|
|
Gastrointestinal disorders
Nausea
|
8.5%
6/71 • Number of events 7
Safety set (SS) consists of subjects who received at least 1 dose of the investigational medicinal product and had at least 1 post-dose safety assessment.
|
4.9%
3/61 • Number of events 3
Safety set (SS) consists of subjects who received at least 1 dose of the investigational medicinal product and had at least 1 post-dose safety assessment.
|
|
Nervous system disorders
Headache
|
5.6%
4/71 • Number of events 5
Safety set (SS) consists of subjects who received at least 1 dose of the investigational medicinal product and had at least 1 post-dose safety assessment.
|
4.9%
3/61 • Number of events 3
Safety set (SS) consists of subjects who received at least 1 dose of the investigational medicinal product and had at least 1 post-dose safety assessment.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee If a multicenter publication is not submitted within twelve (12) months after conclusion, abandonment or termination of the Study at all sites, or after Sponsor confirms there shall be no multicenter Study publication, the Institution and/or such Principal Investigator may publish the results from the Institution site individually.
- Publication restrictions are in place
Restriction type: OTHER