Trial Outcomes & Findings for Drug-Drug Interaction Study to Evaluate the Effect of Colestilan on the Pharmacokinetics of Single Doses of Candesartan Cilexetil in Healthy Subjects (NCT NCT01976572)
NCT ID: NCT01976572
Last Updated: 2026-01-07
Results Overview
Area under the plasma concentration-time curve from time zero up to the last quantifiable time-point
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
18 participants
Primary outcome timeframe
0, 1, 2, 3, 4, 5, 6, 8, 12, 24, 36, and 48 hours post-dose
Results posted on
2026-01-07
Participant Flow
Subjects were recruited at Covance from 14th October 2013.
Participant milestones
| Measure |
Treatment A
On Day 1, a single dose of candesartan (16 mg) was administered. On Day 7, the first daily dose of colestilan (5 g) and candesartan were administered together (T0). On Day 13, candesartan was administered at 1 hour before (T-1) the first daily dose of colestilan, and on Day 19 at 3 hours after (T+3) the first daily dose of colestilan.
|
Treatment B
On Day 1, a single dose of candesartan (16 mg) was administered. On Day 7, candesartan was administered at 1 hour before (T-1) the first daily dose of colestilan. On Day 13, candesartan was administered at 3 hours after (T+3) the first daily dose of colestilan, and on Day 19, the first daily dose of colestilan and candesartan were administered together (T0).
|
Treatment C
On Day 1, a single dose of candesartan (16 mg) was administered. On Day 7, candesartan was administered at 3 hours after (T+3) the first daily dose of colestilan. On Day 13, the first daily dose of colestilan and candesartan was administered together (T0), and on Day 19 candesartan was administered at 1 hour before (T-1) the first daily dose of colestilan.
|
|---|---|---|---|
|
Overall Study
STARTED
|
6
|
6
|
6
|
|
Overall Study
COMPLETED
|
6
|
6
|
6
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Drug-Drug Interaction Study to Evaluate the Effect of Colestilan on the Pharmacokinetics of Single Doses of Candesartan Cilexetil in Healthy Subjects
Baseline characteristics by cohort
| Measure |
All Subjects
n=18 Participants
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=37 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
18 Participants
n=37 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=37 Participants
|
|
Age, Continuous
|
35.1 years
STANDARD_DEVIATION 10.4 • n=37 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=37 Participants
|
|
Sex: Female, Male
Male
|
18 Participants
n=37 Participants
|
PRIMARY outcome
Timeframe: 0, 1, 2, 3, 4, 5, 6, 8, 12, 24, 36, and 48 hours post-dosePopulation: PK Population: All subjects who receive at least one dose of candesartan and have sufficient interpretable PK data.
Area under the plasma concentration-time curve from time zero up to the last quantifiable time-point
Outcome measures
| Measure |
Candesartan Alone
n=18 Participants
Single dose of candesartan (16 mg) only
|
T-1hr
n=18 Participants
Single dose of candesartan (16 mg) with colestilan (5 g three times daily) co-administration at 1 hour before
|
T0hr
n=18 Participants
Single dose of candesartan (16 mg) with colestilan (5 g three times daily) co-administration at the same time
|
T+3hr
n=18 Participants
Single dose of candesartan (16 mg) with colestilan (5 g three times daily) co-administration at 3 hour after
|
|---|---|---|---|---|
|
AUC0-t of Candesartan
|
1118 ng*hr/mL
Standard Deviation 249
|
826 ng*hr/mL
Standard Deviation 308
|
494 ng*hr/mL
Standard Deviation 127
|
759 ng*hr/mL
Standard Deviation 211
|
PRIMARY outcome
Timeframe: 0, 1, 2, 3, 4, 5, 6, 8, 12, 24, 36, and 48 hours post-dosePopulation: PK Population: All subjects who receive at least one dose of candesartan and have sufficient interpretable PK data.
Maximum observed plasma concentration
Outcome measures
| Measure |
Candesartan Alone
n=18 Participants
Single dose of candesartan (16 mg) only
|
T-1hr
n=18 Participants
Single dose of candesartan (16 mg) with colestilan (5 g three times daily) co-administration at 1 hour before
|
T0hr
n=18 Participants
Single dose of candesartan (16 mg) with colestilan (5 g three times daily) co-administration at the same time
|
T+3hr
n=18 Participants
Single dose of candesartan (16 mg) with colestilan (5 g three times daily) co-administration at 3 hour after
|
|---|---|---|---|---|
|
Cmax of Candesartan
|
106.7 ng/mL
Standard Deviation 37.9
|
94.7 ng/mL
Standard Deviation 58.3
|
42.8 ng/mL
Standard Deviation 7.0
|
99.5 ng/mL
Standard Deviation 36.9
|
SECONDARY outcome
Timeframe: 0, 1, 2, 3, 4, 5, 6, 8, 12, 24, 36, and 48 hours post-doseTime of maximum observed plasma concentration
Outcome measures
| Measure |
Candesartan Alone
n=18 Participants
Single dose of candesartan (16 mg) only
|
T-1hr
n=18 Participants
Single dose of candesartan (16 mg) with colestilan (5 g three times daily) co-administration at 1 hour before
|
T0hr
n=18 Participants
Single dose of candesartan (16 mg) with colestilan (5 g three times daily) co-administration at the same time
|
T+3hr
n=18 Participants
Single dose of candesartan (16 mg) with colestilan (5 g three times daily) co-administration at 3 hour after
|
|---|---|---|---|---|
|
Tmax
|
3.00 hr
Interval 2.0 to 4.0
|
3.00 hr
Interval 2.0 to 8.0
|
5.05 hr
Interval 3.0 to 5.12
|
2.05 hr
Interval 2.05 to 5.0
|
SECONDARY outcome
Timeframe: 0, 1, 2, 3, 4, 5, 6, 8, 12, 24, 36, and 48 hours post-doseApparent plasma terminal elimination half-life
Outcome measures
| Measure |
Candesartan Alone
n=18 Participants
Single dose of candesartan (16 mg) only
|
T-1hr
n=18 Participants
Single dose of candesartan (16 mg) with colestilan (5 g three times daily) co-administration at 1 hour before
|
T0hr
n=18 Participants
Single dose of candesartan (16 mg) with colestilan (5 g three times daily) co-administration at the same time
|
T+3hr
n=18 Participants
Single dose of candesartan (16 mg) with colestilan (5 g three times daily) co-administration at 3 hour after
|
|---|---|---|---|---|
|
T1/2
|
13.50 hr
Standard Deviation 3.31
|
9.61 hr
Standard Deviation 1.90
|
10.44 hr
Standard Deviation 2.18
|
10.01 hr
Standard Deviation 1.73
|
Adverse Events
Candesartan Alone (Day 1 to 2)
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Colestilan Alone (Day 3 to 6)
Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths
Candesartan Plus Colestilan (Day 7 to 24)
Serious events: 0 serious events
Other events: 11 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Candesartan Alone (Day 1 to 2)
n=18 participants at risk
|
Colestilan Alone (Day 3 to 6)
n=18 participants at risk
|
Candesartan Plus Colestilan (Day 7 to 24)
n=18 participants at risk
|
|---|---|---|---|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/18 • 24 days
|
11.1%
2/18 • 24 days
|
5.6%
1/18 • 24 days
|
|
Gastrointestinal disorders
Constipation
|
5.6%
1/18 • 24 days
|
0.00%
0/18 • 24 days
|
5.6%
1/18 • 24 days
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.00%
0/18 • 24 days
|
5.6%
1/18 • 24 days
|
0.00%
0/18 • 24 days
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/18 • 24 days
|
5.6%
1/18 • 24 days
|
0.00%
0/18 • 24 days
|
|
Gastrointestinal disorders
Abnormal faeces
|
0.00%
0/18 • 24 days
|
0.00%
0/18 • 24 days
|
5.6%
1/18 • 24 days
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/18 • 24 days
|
5.6%
1/18 • 24 days
|
0.00%
0/18 • 24 days
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/18 • 24 days
|
0.00%
0/18 • 24 days
|
5.6%
1/18 • 24 days
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/18 • 24 days
|
0.00%
0/18 • 24 days
|
5.6%
1/18 • 24 days
|
|
Gastrointestinal disorders
Haematochezia
|
0.00%
0/18 • 24 days
|
0.00%
0/18 • 24 days
|
5.6%
1/18 • 24 days
|
|
Gastrointestinal disorders
Infrequent bowel movements
|
5.6%
1/18 • 24 days
|
0.00%
0/18 • 24 days
|
0.00%
0/18 • 24 days
|
|
Gastrointestinal disorders
Irritable bowel syndrome
|
0.00%
0/18 • 24 days
|
0.00%
0/18 • 24 days
|
5.6%
1/18 • 24 days
|
|
Gastrointestinal disorders
Lip ulceration
|
0.00%
0/18 • 24 days
|
0.00%
0/18 • 24 days
|
5.6%
1/18 • 24 days
|
|
Gastrointestinal disorders
Mouth ulceration
|
0.00%
0/18 • 24 days
|
0.00%
0/18 • 24 days
|
5.6%
1/18 • 24 days
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/18 • 24 days
|
5.6%
1/18 • 24 days
|
0.00%
0/18 • 24 days
|
|
Nervous system disorders
Headache
|
0.00%
0/18 • 24 days
|
11.1%
2/18 • 24 days
|
11.1%
2/18 • 24 days
|
|
Nervous system disorders
Dizziness
|
0.00%
0/18 • 24 days
|
5.6%
1/18 • 24 days
|
11.1%
2/18 • 24 days
|
|
Nervous system disorders
Lethargy
|
0.00%
0/18 • 24 days
|
5.6%
1/18 • 24 days
|
0.00%
0/18 • 24 days
|
|
General disorders
Fatigue
|
0.00%
0/18 • 24 days
|
11.1%
2/18 • 24 days
|
11.1%
2/18 • 24 days
|
|
General disorders
Chest pain
|
0.00%
0/18 • 24 days
|
5.6%
1/18 • 24 days
|
0.00%
0/18 • 24 days
|
|
General disorders
Feeling hot
|
0.00%
0/18 • 24 days
|
5.6%
1/18 • 24 days
|
0.00%
0/18 • 24 days
|
|
General disorders
Pyrexia
|
0.00%
0/18 • 24 days
|
0.00%
0/18 • 24 days
|
5.6%
1/18 • 24 days
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
5.6%
1/18 • 24 days
|
11.1%
2/18 • 24 days
|
0.00%
0/18 • 24 days
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/18 • 24 days
|
5.6%
1/18 • 24 days
|
0.00%
0/18 • 24 days
|
|
Musculoskeletal and connective tissue disorders
Limb discomfort
|
0.00%
0/18 • 24 days
|
5.6%
1/18 • 24 days
|
0.00%
0/18 • 24 days
|
|
Renal and urinary disorders
Pollakiuria
|
5.6%
1/18 • 24 days
|
11.1%
2/18 • 24 days
|
0.00%
0/18 • 24 days
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/18 • 24 days
|
0.00%
0/18 • 24 days
|
5.6%
1/18 • 24 days
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/18 • 24 days
|
0.00%
0/18 • 24 days
|
5.6%
1/18 • 24 days
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
0.00%
0/18 • 24 days
|
0.00%
0/18 • 24 days
|
5.6%
1/18 • 24 days
|
|
Eye disorders
Eyelid skin dryness
|
0.00%
0/18 • 24 days
|
5.6%
1/18 • 24 days
|
0.00%
0/18 • 24 days
|
|
Eye disorders
Ocular hyperaemia
|
0.00%
0/18 • 24 days
|
0.00%
0/18 • 24 days
|
5.6%
1/18 • 24 days
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/18 • 24 days
|
5.6%
1/18 • 24 days
|
5.6%
1/18 • 24 days
|
|
Metabolism and nutrition disorders
Decreased appetite
|
5.6%
1/18 • 24 days
|
5.6%
1/18 • 24 days
|
0.00%
0/18 • 24 days
|
|
Infections and infestations
Catheter site cellulitis
|
0.00%
0/18 • 24 days
|
0.00%
0/18 • 24 days
|
5.6%
1/18 • 24 days
|
|
Psychiatric disorders
Middle insomnia
|
0.00%
0/18 • 24 days
|
0.00%
0/18 • 24 days
|
5.6%
1/18 • 24 days
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.00%
0/18 • 24 days
|
0.00%
0/18 • 24 days
|
5.6%
1/18 • 24 days
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: OTHER